Product Performance Report 2016 - Medtronic · 2019-12-05 · 2016 Medtronic Product Performance...

IntroductionCommitment to QualityContact Information

Introduction

Medtronic uses a prospective, long-term multi-center registry to monitor the performance of certain products atselected centers. The registry is currently conducted utilizing two protocols titled the Implantable SystemsPerformance Registry (ISPR) and the Product Surveillance Registry (PSR). Both protocols collect data on theperformance of Medtronic products; however, PSR captures further information on select patient reported outcomes.Active patients enrolled under the ISPR protocol are in the process of transitioning to the PSR protocol. This 2016Product Performance Report provides data on the devices followed in the registry. Medtronic also incorporates thefindings of Returned Product Analysis (RPA) for devices followed in the registry that are returned to Medtronic.

Depending upon geography, this report may contain information outside approved labeling for Medtronic'scommercially available devices. It is recognized that healthcare providers prescribe approved therapies to meetspecific patient needs; however, Medtronic only directs the use of its products according to geography-specific,approved labeling.

Registry Background

The registry was created by Medtronic to monitor the performance of commercially available infusion and spinalcord stimulation systems. These systems were initiated into the registry in August 2003 and June 2004, respectively.Prior to the development of the registry, Medtronic Neuromodulation typically evaluated patient and productoutcomes by retrospectively analyzing data from Returned Product Analysis (RPA) and complaints data. Theregistry allows Medtronic to prospectively capture valuable real-world information that can be used in conjunctionwith these retrospective and passive data sources. This information is used to guide future product developmentefforts aimed at improving product reliability and quality. The data are also used to measure progress towardimproving product performance to fulfill regulatory requirements. In addition, data from the registry provideinformation about the treatment practices of physicians using these therapies.

This registry was initially designed to track performance of Medtronic's implantable targeted drug delivery systems(infusion pumps and catheters). These surgically-placed devices deliver prescribed medication directly to the fluidaround the spinal cord for the treatment of chronic pain or severe spasticity.

Medtronic's spinal cord stimulation systems (spinal cord neurostimulators, leads, and extensions) for painindications were later added to the registry. Implanted spinal cord neurostimulators send electrical impulses to thespinal cord.

In July 2009, Medtronic’s deep brain stimulation systems (deep brain neurostimulators, leads, and extensions) wereincluded in the registry. Deep brain stimulation (DBS) uses a surgically implanted neurostimulator to deliverelectrical stimulation to targeted areas in the brain.

In April 2010, Medtronic’s sacral neuromodulation systems (neurostimulator, leads, and extensions) were added tothe registry. This implantable system sends electrical pulses through a lead to the sacral nerves to modulate theneural activity that influences the behavior of the pelvic floor, lower urinary tract, urinary and anal sphincters, and

Medtronic Product Performance Report http://professional.medtronic.com/wcm/groups/mdtcom_sg/@m...

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colon.

The registry has collected data from centers across the United States, Europe, and South America. There havebeen 60 centers that have contributed data for targeted drug delivery systems, 75 centers for spinal cord stimulationsystems, 36 centers for deep brain stimulation, and 19 centers for sacral neuromodulation. There are 37, 41, 30,and 11 sites currently active for targeted drug delivery, spinal cord stimulation, deep brain stimulation, and sacralneuromodulation, respectively. Each registry center received Institutional Review Board or Medical EthicsCommittee approval of the registry protocol and associated Informed Consent Forms (ICF). Registry patients signedan ICF prior to enrollment. Each registry center followed its standard clinical practice for device system implantationincluding patient selection, implant methods, and post implant therapy management. Centers were activated afterreceipt of the necessary documentation, completion of training, and approval to access the web-based registrysystem.

Commitment to Quality

Medtronic's commitment to quality has long been stated in our mission, "To strive without reserve for the greatestpossible reliability and quality in our products; to be the unsurpassed standard of comparison and to be recognizedas a company of dedication, honesty, integrity, and service."

In line with this commitment we remain focused on sharing information and appropriate updates with customers on aregular basis. Thus, we are pleased to share the 9th Annual Medtronic Neurostimulation and Targeted Drug DeliverySystems Product Performance Report.

We are proud of our pioneering history at Medtronic and we realize the responsibility that comes with drivinginnovation in technology. As the first and only company to offer a full line of Spinal Cord Stimulation, Deep BrainStimulation, Sacral Neuromodulation and Targeted Drug Delivery Systems therapies, we believe that performancereporting is even more important. We strive for better performance with every new product we develop. This reportshows the evolution of product performance over time and also reveals advances in therapies that come with thisexperience and knowledge. Through this sharing of information we can enable physicians to best leverage state-of-the-art therapy delivery and also understand the performance of our devices to best manage patients.

We have tracked over 14,600 patients in our ongoing post-market registry. The registry has enrolled over 43,900Neuromodulation system components. Components include pumps, catheters, neurostimulators, leads, andextensions. Data on other events not directly attributed to product performance are also included to provideadditional information that may be important for patient management. Although gastric stimulation also involvesneurostimulation, the performance of these systems is not included in the registry.

We welcome your suggestions on content, format, and any information you may have regarding the performance ofMedtronic products. If you have questions or comments, please contact us through the information provided on thenext page.

Thank you for your support.

Andrina HoughamVice President, Clinical Research and Regulatory AffairsMedtronic

Contact Information

We invite our customers to use this telephone number to call with suggestions, inquiries, or specific problemsrelated to our products or the Product Performance Report.

MEDTRONIC, INC.PHONE: (800) 328-0810

Written requests or suggestions can be mailed to:


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MEDTRONICATTN: Todd Weaver, PhD, MPH or Katherine Schiller, PhDMAIL STOP: LS380710 Medtronic Parkway NE, LS380Minneapolis, MN 55432-5604

Editorial Staff

AuthorsTodd Weaver, PhD, MPH, Senior Clinical Research ManagerKatherine Schiller, PhD, Senior Clinical Research SpecialistBrian Van Dorn, Senior Statistician

External MedicalReviewers

Peter Konrad MD, PhD, Nashville, TNKarl Kreder, MD, Iowa City, IARobert Plunkett, MD, Buffalo, NYJohn Sasaki, MD, Pomona, CALisa Stearns, MD, Scottsdale, AZMichael Turner, MD, Indianapolis, IN

Medtronic Review Board

Christopher Irwin, Manager, BiostatisticsAmy Brown, Clinical Research DirectorWilliam Collis-Prather, Clinical Research DirectorSudha Iyer, Clinical Research DirectorKristin Lambrecht, Clinical Research DirectorKelly Haagenson, Senior Medical Affairs Specialist, Medical & Scientific AffairsPeter Rodine, Principal Medical Affairs Specialist, Medical & Scientific AffairsLisa Johanek, Principal Medical Writer, Medical & Scientific AffairsMary Owens, MD, Medical and Scientific AffairsMatt Valitchka, Legal CounselLinnea Burman, Vice President & General Manager, Pelvic Health & GastricTherapiesAndrina Hougham, Vice President, Clinical Research and Regulatory AffairsLothar Krinke, PhD, Vice President & General Manager, Brain Modulation TherapyMatthew Thomas, Vice President & General Manager, Pain Stimulation TherapyCharlie Covert, Vice President & General Manager, Targeted Drug Delivery TherapyDaniel Rowenhorst, Quality DirectorLisa Clark, Senior Manager, Customer QualityChris Christiansen, Regulatory Affairs DirectorPatrick Johnson, Regulatory Affairs DirectorMichelle Wells, PhD, Clinical Research Manager

Trademarks of Medtronic, Inc.

SynchroMed® implantable drug pump

Ascenda® intrathecal catheter PrimeAdvanced® neurostimulator

Synergy® neurostimulator Itrel®3 neurostimulator

Synergy Versitrel® neurostimulator Pisces-Octad® lead

SynergyPlus+® neurostimulator Pisces-Quad® lead


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Restore® implantable neurostimulator Resume® TL lead

RestoreAdvanced® neurostimulator Specify™ lead

RestoreUltra® neurostimulator Soletra® neurostimulator

RestoreSensor® neurostimulator Kinetra® neurostimulator

InterStim® neurostimulator Activa® neurostimulator

RestoreSensor® SureScan® MRI neurostimulator RestoreUltra® SureScan® MRI neurostimulator

PrimeAdvanced® SureScan® MRI neurostimulator SynergyCompact® neurostimulator

RestoreAdvanced® SureScan® MRI neurostimulator Vectris® SureScan® leads

2016 Medtronic Product Performance Report: Data through July 31, 2016.

Therapies

Deep Brain Stimulation for Movement DisordersDeep Brain Stimulation for Psychiatric DisordersGastric Electrical StimulationIntrathecal Baclofen Therapy for Severe SpasticityPercutaneous Tibial NeuromodulationTargeted Drug Delivery for Chronic PainSacral NeuromodulationSpinal Cord Stimulation

Resources

Reimbursement and Practice ManagementMRI GuidelinesResearch Proposal Contacts and GuidelinesClinical Trials RegistryClinical Research Investigator Guidance

Customer Support

Contact UsAddresses and Phone NumbersReimbursement and Support Services

Medtronic.com1. mysunshine.medtronic.com2. Privacy Statement3. Terms of Use4. Customer Support5. Contact Us6.

© 2017 Medtronic


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© 2017 Medtronic

Medtronic.commysunshine.medtronic.comPrivacy StatementTerms of UseCustomer SupportContact Us

Event ClassificationDevice Survival AnalysesReturned Product Analysis

Event Classification

Events currently collected in the registry include all events that appear or worsen during the registry and are a resultof:

Implanted or external componentsImplant procedureInfusion or stimulation therapy

Information on all deaths is also collected regardless of their relatedness to the device, implant procedure, and/ortherapy.

In early versions of the protocol for infusion and spinal cord stimulation systems, an event was reportable only if itrequired a surgical intervention, led to therapy abandonment, or resulted in death. This event threshold wasexpanded for infusion and spinal cord stimulation systems in April 2010 in order to capture additional adverse eventdata.

Additionally, since the protocol expansion, the seriousness (per ISO 14155-1) of adverse events has been assessedand reported by the registry investigators.

For centers participating in the PSR protocol of the registry, specific therapy relevant events are also collected andinclude:

Urinary tract infection for sacral neuromodulationNegative changes in behavior from baseline for deep brain stimulationNew or worsening depression from baseline for deep brain stimulationNew or worsened suicidal ideation from baseline, attempted suicide or completed suicide for deep brainstimulation

By design, not all adverse events experienced by patients during participation were reported in the registry becausethe registry is primarily focused on understanding the long term reliability and performance of Medtronic implantedsystems.

All events reported in the registry are coded using version 17.0 of the Medical Dictionary for Regulatory Activities(MedDRA). Medtronic's own coding system for events related to implanted neuromodulation systems, which do notexist in the MedDRA dictionary, was integrated with the MedDRA dictionary.

Registry Definitions

Adverse Event - any death or undesirable experience (associated with signs, symptoms, illnesses, or other medicalevents) occurring to the patient that appears or worsens during the clinical study and is possibly related to thedevice, implant procedure, and/or therapy.


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Device Event - an issue with any of the implantable or external system components.

Therapy Relevant Event - a specific event type for sacral neuromodulation and deep brain stimulation therapieswhich are collected regardless of relatedness to the device, procedure, or therapy.

Adverse Event/Device Event Flowchart

View Larger Image

Product-Performance or Non-Product Performance Categorization

For analysis purposes, events collected were collapsed into 2 categories: product performance events andnon-product performance events. All events were reviewed by Medtronic to determine if they were productperformance-related (product performance events are events that are possibly due to a device-related issue). Anon-product performance related event was any undesirable experience (associated with signs, symptoms,illnesses, or other medical events) occurring to the patient, and that appears or worsens during the clinical study,that possibly resulted from or was related to the implant procedure, therapy, or delivery of therapy, and cannot beclassified as product performance-related.

Consistency and Accuracy

Consistency and accuracy of event reporting is monitored at four levels: through logic checks built into the studydatabase as center personnel enter information; through review of each event by the study team as it is received byMedtronic; review by the Medical Advisor when necessary; and through routine monitoring at each center perMedtronic standard operating procedures. Monitoring is accomplished through a risk-based approach that alignswith the current FDA guidance on monitoring. Through this approach not every data field is monitored but anemphasis is placed on data related to the primary objective (e.g., events). Clarification and subsequent adjudicationof events may be required for, but is not limited to, the following reasons:

Inconsistency with the protocolsInconsistency with the instructions provided to the centers through training materialsIncomplete or inaccurate event description that makes a reported event reason, event reason detail, and theclinical data appear inadequate or inconsistentMedtronic Customer Support and Vigilance Complaint management requirement for additional informationCenter personnel initiated corrections or additions

Device Survival Analyses


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Device performance is expressed in terms of device survival estimates, where "survival" refers to freedom from aproduct performance event, not the survival of the patient. These survival probabilities are estimated using theKaplan-Meier method.1 The estimates are intended to illustrate the probability that a device will survive for a givennumber of years without a product performance related event.

Active surveillance normally begins at the time of implant and continues until a product performance or censoringevent occurs. In some cases in the registry, active surveillance of a device starts after the device was implanted,which is called left truncation.1 The survival probability of such a device is conditional on survival to the time whenthe device enters the registry. For the PPR analysis, a statistical method to incorporate data from theseretrospectively enrolled devices was applied. Left truncation provides a statistical technique that uses data fromexisting devices while appropriately adjusting the device survival curves for the time the device was not activelyfollowed in the registry. Thus, in some cases sample sizes may fluctuate from one time interval to the next interval.

Throughout this report, cumulative device survival plots are presented. These figures show the percentage ofimplanted devices that remain free from product performance-related events at various time points. This survivalestimate is a good representation of the probability a device will survive a period of time without a productperformance event. For example, a device survival probability of 90% indicates that through the stated follow-uptime, the device had a 10% risk of incurring a product performance event since the time of implant.

The survival curves are statistical estimates. As performance experience accumulates, the accuracy of theestimation improves. Confidence intervals are provided as a way to indicate the degree of certainty of the estimates.Greenwood's formula is used to calculate the standard errors, and the log-log method is used to produce the 2-sided95% confidence bounds.2 This can be roughly interpreted as meaning that the true survival of the device will fallsomewhere in the interval, with 95% probability. When confidence intervals for device models overlap, estimates ofsurvival from product performance-related events are not different between models. When confidence intervals donot overlap, estimates of survival from product performance-related events are different between models.

The device survival curves are presented through all continuous time points where there are at least 20 devices,and are cut off at the last 3-month time point where at least 20 total devices were still being followed. Since thesurvival estimate can become very imprecise with small sample sizes, a minimum of 20 devices must have at least12 months of follow-up as of the report cut-off date to present a survival curve in this report. Device survivalestimates are presented at the device level, not at the system level which involves the combination of 2 or moredevices.

References

Klein, John P., Moeschberger, Melvin L. Survival Analysis Techniques for Censored and Truncated Data, NewYork: Springer-Verlag New York, Inc., 1997.

1.

Lee, Elisa T. (2003) Statistical Methods for Survival Data Analysis — 3rd Edition (Wiley Series in Probabilityand Statistics).

2.

Returned Product Analysis

Registry devices that are returned to Medtronic are analyzed via a Returned Product Analysis (RPA) processfollowing protocols to confirm proper functioning or identification of root cause for any failure or deficiency. Forregistry pumps and neurostimulators that are returned, and for which RPA establishes a root cause or finds noanomaly, results reported herein reflect the RPA finding unless otherwise indicated in this report. When available,RPA findings are also used as one of the sources to identify the root cause of failure or deficiency for catheters andleads. In cases where the center does not explant and/or return a device, the physician-reported event reason isused for classification and analysis purposes.

Medtronic uses data from RPA as well as complaint reports from non-returned product for ongoing qualitymonitoring and improvement efforts. This report presents data from the registry including the results of RPA forreturned devices from registry centers and patients. Data from RPA outside the registry centers and patients are notpresented in this report.


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Therapies


Resources


Customer Support



© 2017 Medtronic

© 2017 Medtronic


Study ParticipantsEvent SummaryPumpsCatheters

Study Participants

Centers


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The following tables and graphs were generated based on data collected between August 7, 2003 and the reportcut-off date of July 31, 2016. Sixty centers enrolled and contributed patients to the targeted drug delivery systemssection of the report.

Patients

As the table below demonstrates, there were 7,459 total targeted drug delivery system patients enrolled throughJuly 31, 2016. As indicated, 58.1% of patients were implanted with a targeted drug delivery system for treatment ofnon malignant pain (pain not related to cancer and its treatment), followed by 21.6% for treatment of spasticity, and18.5% for treatment of malignant pain (pain related to cancer). Primary treatment indication is provided by thephysician.

Targeted Drug Delivery System Primary Treatment Indications

Targeted Drug Delivery System Primary TreatmentIndications

Primary Treatment IndicationaTotal EnrolledPatients(Percent)

Pain 5,709 (76.5%)

Non-Malignant Pain4.332(58.1%)

Malignant Pain1,377(18.5%)

Spasticity 1,611 (21.6%)

Combination 87 (1.2%)


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Non-Malignant Pain & Spasticity 87 (1.2%)

Not Specified 52 (0.7%)

Total Subjects 7,459

a Refer to product labeling for approved indications.

Malignant Pain Sub-IndicationsTotal EnrolledPatients(Percent)a

Location of Pain

Spine/Back 441 (32.0%)

Abdominal/Visceral 296 (21.5%)

Extremity 189 (13.7%)

Pelvic 183 (13.3%)

Thoracic 156 (11.3%)

Head/Neck 80 (5.8%)

Other 76 (5.5%)


Total Patients 1,377

a Percent is based on the number of total patients.

Non-Malignant Pain Sub-IndicationsTotal EnrolledPatients(Percent)

Back Pain without Leg Pain 1,376 (31.1%)

Back Pain with Leg Pain 1,225 (27.7%)

General Neuropathic Condition 176 (4.0%)

CRPS Ia 136 (3.1%)

Peripheral Neuropathy 74 (1.7%)

Joint Pain/Arthritis 63 (1.4%)


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Event Summary

There were 4,934 events reported between August 2003 and July 31, 2016 in patients with targeted drug deliverysystems. Approximately 28% of these events (1,393/4,934) were categorized as product performance-relatedevents and are presented graphically within this report. The 1,393 product performance events occurred in 982 ofthe 7,459 total patients (13.17%) enrolled. In addition, there were 3,541 non-product performance events reported.There were also 1,784 deaths reported for patients with targeted drug delivery systems. None of these deaths werereported as a direct result of a product performance event. Early versions of the protocol required events to bereported only when the event required a surgical intervention, resulted in therapy abandonment, or resulted in death.The required event reporting definition was expanded in April 2010 to include all adverse events related to the

CRPS IIa 34 (0.8%)

General Nociceptive Condition 32 (0.7%)

Osteoporosis 20 (0.5%)

Other 322 (7.3%)


Total Patientsb 4,419

a CRPS is complex regional pain syndrome. CRPS I rarely includesdetectable peripheral nerve injury. CRPS II includes detectableperipheral nerve or plexus injury.b Includes patients with indications of non-malignant pain and acombination of non-malignant pain and spasticity.

Spasticity Sub-IndicationsTotal EnrolledPatients(Percent)

Cerebral Palsy 450 (26.5%)

Multiple Sclerosis 446 (26.3%)

Spinal Cord Injury 241 (14.2%)

Brain Injury 125 (7.4%)

Stroke 68 (4.0%)

Other 94 (5.5%)


Total Patientsa 1,698

a Includes patients with indications of spasticity and a combination ofnon-malignant pain and spasticity.


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device, implant procedure, and/or therapy. The event tables provided below include combined data from theseversions of the protocol.

Targeted Drug Delivery System Product Performance Events

Eventa

Number ofProductPerformanceEvents

Number ofPatients withEventb

Percent ofPatients withEvent (n=7,459)

Catheter occlusionc 280 257 3.45%

Catheterdislodgement

273 236 3.16%

Catheter break/cut 188 169 2.27%

Pump motor stall 132 112 1.50%

Catheter kink 124 113 1.51%

Catheter relatedcomplicationd 56 52 0.70%

Device malfunctione 44 41 0.55%

Catheterdisconnection atpump

41 41 0.55%

Catheter leakage 39 38 0.51%

Pump reservoirvolume discrepancy

33 28 0.38%


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Corrosion and/orgear wear

28 28 0.38%

Pump unable toenter/withdraw fromcatheter access port

22 19 0.25%

Pump underinfusion 20 17 0.23%

Overinfusionf 18 12 0.16%

Pump connectorbreak/cut

17 16 0.21%

Medical devicecomplicationg 12 10 0.13%

Reduced batteryperformance

9 9 0.12%

Deformed pump tube 7 6 0.08%

Device breakage 5 5 0.07%

Catheter access portissue

4 4 0.05%

Device use error 4 4 0.05%

Catheter 3 3 0.04%


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disconnectionbetween cathetersegments

Device alarm issue 3 3 0.04%

Motor feedthroughanomaly

3 3 0.04%

Pump not infusing 3 3 0.04%

Reservoir accessissues due to residue

3 2 0.03%

Catheter damage 2 2 0.03%

Device connectionissue

2 2 0.03%

Device difficult to use 2 2 0.03%

Device issue 2 2 0.03%

Alarm and/orresonator anomaly

1 1 0.01%

Coil shorted to case 1 1 0.01%

Concave pumpshield

1 1 0.01%


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Connector blockproblem

1 1 0.01%

Cracked rotormagnet holder

1 1 0.01%

Device componentissueh 1 1 0.01%

Device deploymentissue

1 1 0.01%

Device infusionissuej 1 1 0.01%

Device telemetryissue

1 1 0.01%

Gear or bridgingresidue

1 1 0.01%

Leaky capacitor 1 1 0.01%

Productsedimentationpresent

1 1 0.01%

Pump inversion 1 1 0.01%

Not Codedj 1 1 0.01%

Totals 1,393 982 13.17%


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a Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term or Medtronic’s coding system term forevents that do not exist in the MedDRA dictionary.b The total number of patients with events may not represent the sum of all rows, as a patient may haveexperienced more than one type of event.c Includes events reported as catheter occlusion and catheter kink/occlusion.d Includes 18 catheter malfunctions, 15 inability to aspirate from catheter, 4 suspected catheter malfunctions, 4coiled catheters, 2 difficulty aspirating catheter, 2 non-functioning distal catheter, 1 inability to aspirate CSF, 1 poorCSF flow, 1 aneurysm in catheter, 1 catheter wrapped in coils and knots, 1 catheter wrapped around pump, 1evidence of catheter wear, 1 catheter failure, 1 no free flow of CSF from spinal segment of catheter, 1 patencyissues of catheter, 1 slight loop in catheter, and 1 catheter occlusion.e Includes 25 PTM malfunctions, 8 suspected catheter malfunctions, 6 pump malfunctions, 1 clinician programmermalfunction, 1 catheter dysfunction, 1 possible pump malfunction, 1 suspected rotor problem, and 1 catheter anchormalfunction.f There were a total of 24 pumps with overinfusion (physician reported or confirmed by returned product analysis).The events for 15 of these pumps are reported in the table above. The remaining 9 pumps had no reported eventsassociated with explant but had returned product analysis confirmed overinfusion (not reflected in the table abovebut included in the occurrence rate of overinfusion indicated in the Pump Events section of this report). The 15pumps represented in the above table had 21 events; 18 events for overinfusion, and 3 events for pump motor stall.g Includes 1 pump connector appeared somewhat worn, 1 pump unable to interrogate, 1 sutureless connectorfailure, 1 roller arm seized to ball bearing, 1 pump beeped, 1 pump in safe state, 1 possible corrosion of pump dueto concentration of drug, 1 possible corrosion of catheter due to concentration of drug, 1 worn catheter connector, 1metal clips on sutureless connector bent, 1 prescription table corruption, and 1 pump absorption of drug.h Includes 1 event reported as broken anchor.i Includes 1 event reported as slow dosing at refills.j Event that had not been MedDRA-coded at the time of the report cut-off.

A total of 1,054 (75.7%) of the 1,393 product performance events were related to the catheter, 274 (19.7%) wererelated to the pump, 38 (2.7%) were reported as related to an external device, 17 (1.2%) were related to “multipleetiologies,” which includes events where at least one device and one non-device etiology was indicated, 3 (0.2%)were related to surgery/anesthesia, 2 (0.1%) were related to incisional site/device tract, 2 (0.1%) were related toMRI, 1 (0.1%) was related to programming/refill, 1 (0.1%) was related to medication, and 1 (0.1%) was related tosome “other” etiology. Relatedness is determined by the physician.

Product Performance Events by Relatednessa


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a Each event could have more than one etiology.

Targeted Drug Delivery System Non-Product Performance Events(including adverse eventsa and device events, excluding deaths andnormal battery depletions)

Eventb

Number ofNon-ProductPerformanceEvents

Therapeutic and nontherapeutic effects (excludingtoxicity)

998

Adverse drug reaction 725

Drug withdrawal syndrome 121

Therapeutic product ineffective 99

Therapeutic response decreased 40

No therapeutic response 10

Otherc 3

Administration site reactions 622

Implant site pain 251

Implant site extravasation 157


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Implant site erosion 34

Implant site erythema 29

Catheter site pain 22

Inflammatory mass (Possible) 18

Catheter site fibrosis 17

Implant site haematoma 16

Implant site swelling 14

Inflammatory mass (Confirmed) 13

Implant site inflammation 6

Otherc 45

Infections - pathogen unspecified 322

Inplant site infection 218

Wound infection 35

Meningitis 22

Infection 18

Incision site infection 14

Otherc 15

Device issues 317

Pump inversion 158

Pump migration 74

Device difficult to use 26

Device malfunction 19

Pump reservoir volume discrepancy 6


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Device use error 5

Catheter break/cut 5

Pump unable to enter/withdraw from catheter access port5

Otherc 19

Complications associated with device 226

Pump motor stalld 186

Medical device discomfort 27

Medical device complicatione 5

Drug-related pump anomaly 5

Otherc 3

General system disorders Not Elsewhere Classified(NEC)

214

Pain 132

No anomaly found by RPAf 40

Oedema peripheral 18

Asthenia 5

Otherc 19

Neurological disorders (NEC) 212

Cerebrospinal fluid leakage 102

Hypoaesthesia 43

Sedation 16

Somnolence 15

Paraesthesia 10


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Hyperaesthesia 8

Otherc 18

Procedural related injuries and complications NEC 195

Wound dehiscence 67

Seroma 35

Post lumbar puncture syndrome 27

Procedural complication 8

Anaesthetic complication 5

Otherc 53

Medication errors 44

Overdose 41

Otherc 3

Muscle disorders 38

Muscular weakness 30

Muscle spasms 8

Headaches 37

Headache 37

Urinary tract signs and symptoms 34

Urinary retention 25

Dysuria 7

Otherc 2

Neuromuscular disorders 31

Muscle spasticity 27


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Otherc 4

Epidermal and dermal conditions 26

Erythema 9

Pruritus 6

Otherc 11

Gastrointestinal signs and symptoms 22

Nausea 11

Vomiting 7

Other c 4

Musculoskeletal and connective tissue disordersNEC

21

Back pain 12

Otherc 9

Exposures, chemical injuries and poisoning 19

Toxicity to various agents 19

Psychiatric disorders NEC 18

Mental status changes 15

Otherc 3

Bacterial infectious disorders 16

Inmplant site cellulitis 7

Cellulitis 5

Otherc 4

Tissue disorders NEC 16


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Impaired healing 15

Otherc 1

Vascular haemorrhagic disorders 9

Haematoma 9

Therapeutic procedures and supportive care NEC 8

Incisional drainage 5

Otherc 3

Gastrointestinal motility and defaecation conditions 6

Constipation 6

Mental impairment disorders 6

Memory impairment 5

Otherc 1

Skin and subcutaneous tissue disorders NEC 6

Skin erosion 6

Otherc 78Total 3,541

a Adverse events associated with product performance events are not included in this table.b Medical Dictionary for Regulatory Activities (MedDRA) High-Level Group Terms and Preferred Terms orMedtronic's own coding system terms for events that do not exist in the MedDRA dictionary.c Composed of event codes with fewer than 5 events each.d 186 pump motor stalls occurred due to MRI and recovered in less than 24 hours with no pump issues.e Includes events reported as 1 pump poorly positioned,1 difficulty locating pump port due to patient weight gain, 1possible catheter sheath, 1 inadvertent overfilling of the pump at refill, and 1 mis-filling of pump into pocket.f For products that are returned with a suspected device issue, and RPA establishes a root cause or finds noanomaly, results reported herein reflect the finding from Returned Product Analysis (RPA).

There were 1,784 deaths reported for patients with targeted drug delivery systems. None of the deaths werereported as a direct result of a product performance event. One death was reported by the physician as possiblyrelated to the intrathecal medications in a patient who expired due to pulmonary embolism. A second death wasreported by the physician as due to acute respiratory failure following a device procedure, and was reported as


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possibly related to the device and implant procedure. A total of 1,086 (60.9%) of deaths occurred in patientsreceiving therapy for malignant pain, 528 (29.6%) for non-malignant pain, 164 (9.2%) for spasticity, 4 (0.2%) fornon-malignant pain and spasticity, and 2 (0.1%) for patients whose primary indication was not specified.

Deaths by Primary Indication

Primary Indicationa N (%)

Malignant pain 1,086 (60.9%)

Non-malignant pain 528 (29.6%)

Spasticity 164 (9.2%)

Non-Malignant Pain & Spasticity 4 (0.02%)

Not specified 2 (0.1%)

Total 1,784


Pumps

From August 2003 to the report cut-off date of July 31, 2016, there were 9,014 pumps followed in the registry. Thedifference between the total number of patients (n=7,459) versus pumps is due to the fact that some patients weresubsequently re-implanted with a pump multiple times. The aggregate prospective follow-up time for all pumps was237,699 months (19,808 years). The table below provides the number and percentage of pumps by model.

Pumps by Model

Model Name Number of Pumps (%)

SynchroMed II 7,825 (86.8%)

Unspecified 2 (<0.1%)

Pumps No Longer Manufactured

SynchroMed EL 1,182 (13.1%)

SynchroMed 5 (<0.1%)

Total 9,014 (100%)

Pump Events

There were 279 product performance-related events with an underlyingreported etiology related to pump function.

274 events had a pump etiology, and 5 events had both a pump


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and other etiology (including device and non-device).138 pumps were analyzed by Medtronic Returned ProductAnalysis (RPA) with the following analysis findings: 66motor stalls, 28 corrosion and/or gear wear, 17overinfusion, 9 reduced battery performance, 6 deformedpump tube, 3 motor feedthrough anomaly, 2 reservoiraccess issue due to residue, 1 alarm and/or resonatoranomaly, 1 coil shorted to case, 1 concave pump shield, 1cracked rotor magnet holder, 1 leaky capacitor, 1 gear orbridging residue, and 1 medical device complication. Ofthese 138 pumps with RPA-confirmed malfunction events,26 were originally reported as non-product performance-related battery depletions by the physician.

The current return rate of pumps to Medtronic RPAwas 1067/3,980 (26.8%). The proportion was basedupon the number of registry pumps received byRPA, divided by the total number of explantedpumps plus the total number of pumps in patientswho expired.

141 events were characterized based upon physicianreport only (pumps were not returned to Medtronic) andincluded: 63 events due to physician-reported motor stalls,28 pump reservoir discrepancies, 17 pump underinfusion,9 device malfunctions, 6 medical device complications, 5pump unable to enter/withdraw from catheter access port,3 pump not infusing, 3 device alarm issues, 2 catheterocclusions, 2 pump connector break/cut, 1 catheterbreak/cut, 1 device telemetry issue, and 1 overinfusion.

224 were the initial product performance event that affectedpump survival estimates.

In addition to the 279 product performance-related events, there were12 pump events reported as normal battery depletion by the physician,which were returned to Medtronic and had a RPA observation of highbattery resistance. For this analysis, these pumps were categorized ashaving non-product performance-related battery depletion events,because they represented normal implant duration (ranging from 5.6-6.8years) with no associated physician or patient complaint.

Medtronic executed a field action in March 2014 informing healthcareprofessionals of overinfusion associated with the SynchroMed IIInfusion System. In September 2016, an updated customer letter wasprovided which stated an overinfusion occurrence rate for registrypatients. This rate was based on pumps which had both laboratoryoverinfusion through returned product analysis and an in-vivo complaintof either clinical overinfusion symptoms or lower than expected residualvolume. This definition was used because environmental factors duringshipping may impact the results of returned product testing. There were5 pumps in the registry that met this definition as stated in the customerletter. The 5 pumps with overinfusion provided 95% confidence that theoccurrence rate is less than 0.0014 (0.14%).

The laboratory overinfusion rate for all registry pumps with overinfusionfound through returned product analysis was also assessed. As of July31, 2016, this included the 5 pumps described above in the customer


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letter, and 18 additional pumps for a total of 23 pumps from registrypatients with laboratory overinfusion. Of these 23 pumps with laboratoryoverinfusion, 14 had an event reported in the registry, and the remaining9 had no reported events associated with the pump. The 23 findings oflaboratory overinfusion occurred in 7,825 SynchroMed II pumpsincluded in the registry at the time of analysis, providing 95%confidence that the occurrence rate is less than 0.0042 (0.42%).

In addition to the 23 pumps with laboratory overinfusion after returnedproduct analysis, there was 1 pump with physician reported overinfusionthat was not returned for analysis. Combining the physician reportedand laboratory overinfusion (n=24) provided 95% confidence that thetotal occurrence rate is less than 0.0043 (0.43%). Medtronic continuesto monitor pump performance relative to overinfusion.

Overinfusion Rate

In Vivo &LaboratoryOverinfusiona

LaboratoryOverinfusionb

Laboratory orPhysicianReportedc

Overinfusion

Number ofPumps

5 23 24

OccurrenceRated 0.14% 0.42% 0.43%

a From September 2016 Field Action letter. Rate based on total of 7,505pumps (January 31, 2016 data cut-off).b Laboratory overinfusion by Returned Product Analysis. Rate based ona total of 7,825 pumps (July 31, 2016 data cut-off).c There was one pump with physician reported overinfusion which wasnot returned for analysis. Rate based on a total of 7,825 pumps (July31, 2016 data cut-off).d Upper one-sided exact 95% confidence interval.

For the purposes of survival analysis, a device’s follow-up time is cut-offfor one of three reasons: 1) the occurrence of a product performance-related event; 2) the occurrence of a non-product performance-relatedor censoring event; or 3) the device is event-free and censored at thepatient’s last follow-up prior to the data cut-off. For pumps:

224 were cut-off due to product performance-related events.6,412 were censored in the survival analysis for the followingreasons: patient expired, pump explanted, site termination,patient discontinued, patient lost to follow-up, other pumpmodification, therapy suspended, or non-product performancepump-related event with no associated intervention.2,378 were free from product performance-related events and


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Pump Survival

The figures and tables below represent pump survival and 95% confidence intervals where at least 20 pumpscontributed to each 3-month interval. Medtronic chose to voluntarily discontinue the SynchroMed EL pump in August2007 in the United States.

Model 8627-18 SynchroMed EL 18mL: Survival from Pump Events

Data are shown if there are at least 20 devices in each 3-month interval.

View Larger Image

Pump Characteristics

Model Name SynchroMed II (18 mL)

FDA Approval Date Mar 1999

Pumps Enrolled 1,148

Pumps Currently Active in Study 1

Device Events 34

Cumulative Months of Follow-up 31,052

censoring events, were censored at the last follow-up visit prior tothe report cut-off.


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Summary TablePump Event Total

Corrosion and/or gear wear 17

Pump underinfusion 6

Pump motor stall 5

Medical device complicationa 2

Cracked rotor magnet holder 1

Gear or bridging residue 1

Motor feedthrough anomaly 1

Reduced battery performance 1

Total Pump Events 34

a Includes 1 event for unable to interrogate/program pump and 1 roller arm seized to ball bearing.

Time IntervalSurvival(95% Confidence Intervals)

Sample Size

1 yr98.8%(95.3%, 99.7%)

181

2 yrs97.4%(94.2%, 98.9%)

374

3 yrs95.8%(92.6%, 97.6%)

535

4 yrs94.9%(91.8%, 96.9%)

590

5 yrs93.7%(90.5%, 95.8%)

468

6 yrs92.3%(88.9%, 94.7%)

245

7 yrs91.3%(87.6%, 94.0%)

108

8 yrs90.4%(86.1%, 93.4%)

36

at 99 mo90.4%(86.1%, 93.4%)

23


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Model 8627-18 SynchroMed EL 18mL: Specifications

Expected battery lifea 3-7 years

Thickness 1.08 in (27.5 mm)

Diameter (with integral access port) 3.35 in (85.2 mm)

Capacity 18.0 mL

Minimal Programmable Flow Rateb 0.048 mL/day

Maximum Programmable Flow Rateb 21.6 mL/day

a Dependent on flow rateb Actual limits depend on pump calibration constant and selected infusion mode.

Model 8637-20 SynchroMed II 20mL: Survival from Pump Events


View Larger Image



FDA Approval Date Sep 2003


Pumps Currently Active in Study 1,167


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Device Events 62


SynchroMed II 20mL Event Summary TablePump Event Total

Pump motor stall 25



Device malfunctiona 4

Overinfusion 3

Pump unable to enter/withdraw from catheter access port 3

Medical device complication b 2

Motor feedthrough anomaly 2


Alarm and/or resonator anomaly 1

Catheter occlusion 1

Deformed pump tube 1

Device alarm issue 1

Device telemetry issue 1

Pump connector break/cut 1

Pump not infusing 1


Reservoir access issues due to residue 1


a Includes 3 events for pump malfunction and 1 event for suspected rotor problem.bIncludes 1 event for pump beeped and 1 event for pump in safe state.


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Sample Size

1 yr99.8%(99.5%, 99.9%)

2,027

2 yrs99.4%(99.0%, 99.7%)

1,623

3 yrs98.7%(98.1%, 99.2%)

1,196

4 yrs97.9%(97.0%, 98.6%)

869

5 yrs96.6%(95.2%, 97.5%)

612

6 yrs93.9%(91.8%, 95.4%)

391

at 81 mo89.2%(84.3%, 92.6%)

43

Model 8637-20 SynchroMed II 20mL: Specifications



Diameter 3.4 in (87.5 mm)

Capacity 20.0 mL


Maximum Programmable Flow Rateb 24 mL/day

Minimum Rate Infusion Modec 0.006 mL/day

a Dependent on flow rateb Actual limits depend on pump calibration constant and selected infusion mode.c Nontherapeutic (if therapy is to be temporarily discontinued)

Model 8637-40 SynchroMed II 40mL: Survival from Pump Events



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View Larger Image





Pumps Currently Active in Study 1,393

Device Events 127


SynchroMed II 40mL Event Summary TablePump Event Total

Pump motor stall 67



Overinfusion 8





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Device malfunction a 4

Device alarm issue 2

Medical device complication b 2

Pump not infusing 2


Catheter occlusion c 1

Coil shorted to case 1

Concave pump shield 1

Leaky capacitor 1




a Includes 2 events for pump malfunction, 1 event for suspected pump malfunction, and 1 event for suspectedcatheter dysfunction attributed to both pump and catheter.b Includes 1 event for under medicated event that was attributed to the pump and 1 possible corrosion of pump dueto concentration of drug.c Includes 1 event for catheter occlusion that was attributed to the pump and catheter.


Sample Size

1 yr99.2%(98.9%, 99.5%)

2,564

2 yrs98.7%(98.2%, 99.1%)

1,857

3 yrs97.7%(96.9%, 98.2%)

1,313

4 yrs95.9%(94.7%, 96.8%)

902

5 yrs92.2%(90.4%, 93.7%)

591

6 yrs88.4%(85.9%, 90.5%)

351


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at 81 mo83.7%(77.4%, 88.4%)

37

Model 8637-40 SynchroMed II 40mL: Specifications


Thickness 1.0 in (26 mm)

Diameter 3.4 in (87.5 mm)

Capacity 40.0 mL


Maximum Programmable Flow Rateb 24 mL/day

Minimum Rate Infusion Modec 0.006 mL/day

a Dependent on flow rateb Actual limits depend on pump calibration constant and selected infusion mode.c Nontherapeutic (if therapy is to be temporarily discontinued)

Pump Survival Summary


Model Name FamilyFDAApprovalDate

PumpsEnrolled

PumpsCurrentlyActivein Study

DeviceEventsa

CumulativeMonths ofFollow-up

SynchroMedEL (18 mL)

SynchroMed EL Mar 1999 1,148 1 34 31,052

SynchroMed II(20 mL)

SynchroMed II Sep 2003 3,049 1,167 62 94,287


SynchroMed II Sep 2003 4,776 1,393 127 111,401

a There were a total of 279 pump-related events reported to the registry, but only 223 events included in thissummary table. The remaining events either occurred in pump models for which no device survival curves arepresented due to an insufficient number of enrolled devices (i.e., SynchroMed EL 10 mL[n=1]) or were subsequentevents (ie additional events that occurred after the survival censoring event) that did not affect the device survivalestimates.

Device Survival Probability (95% Confidence Intervals) –Table 1 of2

Model Name 1 yr 2 yrs 3 yrs 4 yrs 5 yrs 6 yrs 7 yrs 8 yrs


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SynchroMed EL(18 mL)

98.8%(95.3%,99.7%)

97.4%(94.2%,98.9%)

95.8%(92.6%,97.6%)

94.9%(91.8%,96.9%)

93.7%(90.5%,95.8%)

92.3%(88.9%,94.7%)

91.3%(87.6%,94.0%)

90.4%(86.1%,93.4%)


99.8%(99.5%,99.9%)

99.4%(99.0%,99.7%)

98.7%(98.1%,99.2%)

97.9%(97.0%,98.6%)

96.6%(95.2%,97.5%)

93.9%(91.8%,95.4%)

- -


99.2%(98.9%,99.5%)

98.7%(98.2%,99.1%)

97.7%(96.9%,98.2%)

95.9%(94.7%,96.8%)

92.2%(90.4%,93.7%)

88.4%(85.9%,90.5%)

- -

Device Survival Probability (95% Confidence Intervals) –Table 2 of 2

Model Name 5 yrs 6 yrs 7 yrs 8 yrs

SynchroMed EL (18mL)

93.7%(90.5%, 95.8%)

92.3%(88.9%, 94.7%)

91.3%(87.6%, 94.0%)

91.3%(87.6%, 94.0%)

SynchroMed II (20mL)

96.6%(95.2%, 97.6%)

94.7%(92.7%, 96.2%)

- -

SynchroMed II (40mL)

93.4%(91.5%, 94.9%)

90.0%(87.4%, 92.10%)

- -

Product Performance of SynchroMed II Pumps Exposed to On-Label and Off-Label Medications

The purpose of this section of the report is to provide additional information regarding the product performance ofSynchroMed II pumps exposed to On-Label and Off-Label medications. This section contains information outsidethe FDA approved labeling for Medtronic's SynchroMed II Infusion System. It is recognized that healthcare providersprescribe therapies to meet specific patient needs; however, Medtronic only directs the use of its products accordingto FDA approved labeling. Medtronic does not market its products for Off-Label indications and makes norepresentations regarding the efficacy for Off-Label uses. Infumorph®, Prialt®, Lioresal® and Gablofen® are the onlyintrathecal FDA approved formulations for the Medtronic SynchroMed II Infusion System. The long term drugstability/compatibility and safety and/or efficacy of drugs not FDA approved for use with the SynchroMed II InfusionSystem has not been established.

Patient status updates were obtained every 6 months or until discontinuation of therapy or the patient was lost tofollow-up. Medications within the pump were recorded at each 6-month follow-up. This provided a snapshot ofmedication use at these points in time. The registry did not capture every medication or medication concentrationused in the pump since any medication or concentration changes that occurred between follow-up visits were notrecorded.

Pump Groups – On/Off Label Categorization

There were 6,666 patients enrolled in the registry that had SynchroMed II pumps implanted. Of these patients, 56%were female and 44% were male with a mean age of 54.0 (SD = 17.3). Of the 7,825 SynchroMed II pumps enrolledthrough July 31, 2016, at least one drug record was available for 7,519 pumps. If a pump had no drug records, thepump was not classified, and was excluded from analyses comparing On-Label to Off-Label. Pumps werecategorized as being On7ndash; or Off-Label using the following criteria:

On-Label: If a pump has at least one drug record in the registry, and none of the records show Off-Label drugexposure, that pump is considered On-Label even if the complete drug history of that pump is unknown.

For pumps used for pain patients, if the drug record has only one drug and it is morphine sulfate orziconotide these pumps are considered On-Label.


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o For pumps used for spasticity patients, if the drug record has only one drug, and it is baclofen,Lioresal® or Gablofen®, that drug record is considered On-Label. Note: The classification was based onthe name of the drug only, not the reported concentration of the drug.Pumps with an On-Label drug history and currently containing preservative free water or preservativefree saline, or if previously contained preservative free water/saline and currently containing on-labeldrug were considered On-Label.

Off-Label: Any drugs not specified above within the approved indications are considered Off-Label.Additionally, any drug record with more than one drug at a time in the pump (admixture) is consideredOff-Label.

If a pump had any known exposure to Off-Label drugs (i.e., the Off-Label data have been collected inthe registry), that pump is considered Off-Label, regardless of the amount of exposure time.If a pump is filled with a medication that was reported as compounded, that pump is consideredOff-Label.

Data Analysis

Survival estimates were calculated using the methods described in the Methodology section of this report. Statisticaltesting that compared survival curves was performed using a Cox proportional-hazards model. Since the survivalestimate may become very imprecise with small sample sizes, Medtronic Neuromodulation’s registry truncatesdevice survival curves when the sample size is less than 20 active devices. At this threshold, one device failureyields a 5% decrease in cumulative survival. Additionally, the standard error for this survival estimate isapproximately 5% (depending on previous conditional survival estimates), with 95% confidence intervals ofapproximately ± 10%. Overall, this large variability of 20% around the cumulative survival estimate would greatlyreduce the precision for the point estimate.

Pump survival from product performance-related events was calculated and compared for the following groups:

All pumps: On-Label vs. Off-Label Drugs (including all indications)Pain: On-Label vs. Off-Label Drugs (including all pain)Spasticity: On-Label vs. Off-Label Drugs (including all spasticity)

Additionally, the cumulative failure rate (i.e. the estimated probability that a pump will have a product performance-related event by a given time point) is presented in table and graph formats for each of the sub-groups listed above.

Results

Total Study Population: A total of 2,330 SynchroMed II pumps were classified as On-Label where there was noevidence of Off-Label drug/admixture exposure. A total of 5,189 pumps were classified as Off-Label where therewas evidence of pump exposure to an Off-Label drug/admixture.

Demographic table

Indication a: N (Row %)On-LabelN=2,330

Off-LabelN=5,189

Non-Malignant Pain 748 (16.9%) 3,685 (83.1%)

Malignant Pain 38 (3.0%) 1,225 (97.0%)


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There were a total of 189 reported SynchroMed II pump failures (i.e. had product performance event) during thestudy observation period. In addition to the 189 pump failures, there were 12 pump events reported as normalbattery depletion, but had a Returned Product Analysis (RPA) observation of high battery resistance. For thisanalysis, these pumps were not considered failures because they represented normal implant duration ranging from5.6 – 6.8 years with no associated physician or patient complaint. Three of the 189 pump failure events occurred inpumps with no drug records available. Of the remaining 186 SynchroMed II pump failures, 92 were classified aspump failure due to motor stall (with or without documented motor corrosion). The remaining pump failures were dueto events such as corrosion and/or gear wear, inconsistent pump reservoir volume, pump under infusion, and othernon-conforming reasons. Overall, the rate of pump failures in this cohort was 2.5% (186/7,519) with a medianfollow-up of 19.8 months.

For the 92 pump failures due to motor stall, 44 of the events were associated with the patient presenting clinicalsigns and symptoms of possible drug withdrawal or increasing pain or spasticity. The other 48 events had no patientreported signs and symptoms associated with the event, but had a physician report of a motor stall occurrence.There were no issues reported when pumps were replaced and/or re-started, such as drug overdose. None of thepump failures resulted in patient death.

The table below presents SynchroMed II pump survival for the entire population and is stratified by the On-Label orOff-Label pump group.

Total study population: Survival from product performance-related pump events for all indications, byOn/Off-Label drug exposure for SynchroMed II pumps

Category Time Interval 1 yr 2 yrs 3 yrs 4 yrs 5 yrs 6 yrs 81 mo 7 yrs 87 mo

All Pumps

Survival 99.5% 99.0% 98.1% 96.8% 94.3% 91.1% 86.3% 85.1% 85.1%

Numberofpumps

4,511 3,433 2,482 1,747 1,192 740 80 30 21

On-LabelDrugs

Survival 99.7% 99.5% 98.8% 98.1% 96.3% 94.5% 92.6% - -

Numberofpumps

1,481 1,131 811 563 398 233 20 - a - a

Off-LabelDrugs

Survival 99.4% 98.8% 97.8% 96.2% 93.4% 89.5% 84.0% 82.4% -

Numberofpumps

3,030 2,302 1,671 1,184 794 507 60 21 - a

a Sample size is less than 20 active devices at 7 years for On-Label pump group, and at 87 months for both On andOff-Label pump groups.

The cumulative survival curve of the SynchroMed II pump for the entire population, and stratified by the On-Labelor Off-Label pump group, is shown below.

SynchroMed II cumulative survival (All therapies)



36 of 202 6/12/17, 9:03 AM

View Larger Image

The table and figure below present the complementary cumulative failure rate estimates (Failure=100%-Survival),with the scale of the figure expanded to more clearly show the differences between the groups. The table and graphdepict the cumulative failure rate over time and estimate the risk of pump failure for specific implant durations (i.e.time period from pump implant). Overall, the pumps with known Off-Label drug exposure had a 1.9 times greaterrisk of failure than pumps with no known Off-Label drug exposure (p=0.0004).

Total study population: Cumulative failure of SynchroMed II pumps due to product performance-relatedpump events for all indications, by On/Off-Label drug exposure

Category Time Interval 1 yr 2 yrs 3 yrs 4 yrs 5 yrs 6 yrs 81 mo 7 yrs 87 mo

All Pumps

Failure 0.5% 1.0% 1.9% 3.2% 5.7% 8.9% 13.7% 14.9% 14.9%

Numberofpumps

4,511 3,433 2,482 1,747 1,192 740 80 30 21

On-LabelDrugs

Failure 0.3% 0.5% 1.2% 1.9% 3.7% 5.5% 7.4% - -

Numberofpumps

1,481 1,131 811 563 398 233 20 -a -a

Off-LabelDrugs

Failure 0.6% 1.2% 2.2% 3.8% 6.6% 10.5% 16.0% 17.6% -

Numberofpumps

3,030 2,302 1,671 1,184 794 507 60 21 -a

a Sample size is less than 20 active devices at 7 years for On-Label pump group, and at 87 months for both On andOff-Label pump groups.

SynchroMed II cumulative failure (All therapies)


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View Larger Image

Overall Summary and Limitations

Pump failures have been observed in pumps with both On-Label and Off-Label medications used for allindications over the follow-up period.Off-Label medication exposure is associated with an overall 1.9 times greater risk of pump failure comparedto On-Label medication exposure for the entire pump population. The rate of pump failure accelerates in theOff-Label group after 36 months of follow-up. At 81 months of follow-up, the survival from pump failure forOn-Label pumps was 92.6%, compared to a survival of 84.0% for Off-Label pumps.The data represent the reported registry experience with a median follow-up time of 19.8 months. The longerterm data are based on a lower number of pumps and are subject to change as more follow-up data areobtained via the registry. Survival curve truncation or plateaus do not imply that the implanted devices will notbe adversely impacted beyond the time points of the current data.The On-Label pump group was comprised of 66% spasticity as the indication (1,544 vs. 786: Spasticityversus Pain pumps respectively). On the other hand, the Off-Label group consisted of 95% pain indications(4,910 vs. 187: Pain versus Spasticity pumps respectively).Medication use was recorded as a snapshot at the time of follow-up. It is possible that some On-Label pumpsreceived Off-Label medications in between 6-month follow-up periods. In addition, it is possible that somepumps designated as On-Label received compounded formulation of an On-Label equivalent (i.e. Lioresal)but was not designated as such in the registry database.The time a pump was exposed to an Off-Label medication was not assessed. It is possible that someOff-Label pumps were exposed only for a brief time period (e.g. < 6 months).The risk of pump failure by type of drug was not assessed. Many Off-Label pumps were exposed to multiplemedications over the life span of the pump. This limits the ability to associate a specific drug, compoundeddrug, drug concentration, or drug combination with increased pump failure risk.

Pain Study Population: A total of 786 SynchroMed II pumps were classified as On-Label for pain therapy, wherethere was no evidence of Off-Label drug/admixture exposure. A total of 4,910 pumps were classified as Off-Labelwhere there was evidence of pump exposure to an Off-Label pain drug/admixture.

The table below presents SynchroMed II pump survival for the Pain indications and is stratified by the On-Label orOff-Label pump group.

Pain study population: Survival from product performance-related pump events for Pain indications, byOn/Off-Label drug exposure for SynchroMed II pumps


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Categorya Time Interval 1 yr 2 yrs 3 yrs 4 yrs 5 yrs 6 yrs 75 mo 81 mo

PainOverall

Survival 99.4% 98.8% 97.8% 96.2% 93.4% 89.6% 88.8% 83.7%

Numberofpumps

3,290 2,446 1,748 1,202 805 514 414 59

PainOn-Label

Survival 99.6% 98.9% 97.2% 97.2% 95.7% 95.7% 95.7% -

Numberofpumps

444 285 178 97 61 37 31 - b

PainOff-Label

Survival 99.4% 98.8% 97.9% 96.1% 93.2% 89.1% 88.2% 83.2%

Numberofpumps

2,846 2,161 1,570 1,105 744 477 383 54

a Refer to product labeling for approved Pain indications.b Sample size is less than 20 active devices at 81 months for Pain On-Label pump group

The cumulative survival of the SynchroMed II pump for the Pain indications, and stratified by the On-Label orOff-Label pump group, is shown below.

SynchroMed II cumulative survival (Pain)


View Larger Image

The table and figure below present the complementary cumulative failure rate estimates (Failure=100%-Survival),with the scale of the figure expanded to more clearly show the differences between the groups. The difference insurvival between the On-Label and Off-Label groups for the pumps in the pain population was similar to what wasobserved for the entire population (all therapies). There was no statistically significant difference in the risk of failure


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between the On-Label and Off-Label pumps implanted for the treatment of pain (p=0.31); however, the limitednumber of On-Label pumps may be insufficient to detect a difference.

Pain study population: Cumulative failure of SynchroMed II pumps due to product performance-relatedpump events for Pain indications, by On/Off-Label drug exposure

Categorya TimeInterval 1 yr 2 yrs 3 yrs 4 yrs 5 yrs 6 yrs 75 mo 81 mo

PainOverall

Failure 0.6% 1.2% 2.2% 3.8% 6.6% 10.4% 11.2% 16.3%

Numberofpumps

3,290 2,446 1,748 1,202 805 514 414 59

PainOn-Label

Failure 0.4% 1.1% 2.8% 2.8% 4.3% 4.3% 4.3% -

Numberofpumps

444 285 178 97 61 37 31 - b

PainOff-Label

Failure 0.6% 1.2% 2.1% 3.9% 6.8% 10.9% 11.8% 16.8%

Numberofpumps

2,846 2,161 1,570 1,105 744 477 383 54

a Refer to product labeling for approved Pain indications.b Sample size is less than 20 active devices at 81 months for Pain On-Label pump group.

SynchroMed II cumulative failure (Pain)


View Larger Image


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Pump failures have been observed in pumps with both On-Label and Off-Label medications used for allindications over the follow-up period.Off-Label medication exposure is associated with an overall 1.9 times greater risk of pump failure comparedto On-Label medication exposure for the entire pump population. The rate of pump failure accelerates in theOff-Label group after 36 months of follow-up. At 81 months of follow-up, the survival from pump failure forOn-Label pumps was 92.6%, compared to a survival of 84.0% for Off-Label pumps.The data represent the reported registry experience with a median follow-up time of 19.8 months. The longerterm data are based on a lower number of pumps and are subject to change as more follow-up data areobtained via the registry. Survival curve truncation or plateaus do not imply that the implanted devices will notbe adversely impacted beyond the time points of the current data.The On-Label pump group was comprised of 66% spasticity as the indication (1,544 vs. 786: Spasticityversus Pain pumps respectively). On the other hand, the Off-Label group consisted of 95% pain indications(4,910 vs. 187: Pain versus Spasticity pumps respectively).Medication use was recorded as a snapshot at the time of follow-up. It is possible that some On-Label pumpsreceived Off-Label medications in between 6-month follow-up periods. In addition, it is possible that somepumps designated as On-Label received compounded formulation of an On-Label equivalent (i.e. Lioresal)but was not designated as such in the registry database.The time a pump was exposed to an Off-Label medication was not assessed. It is possible that someOff-Label pumps were exposed only for a brief time period (e.g. < 6 months).The risk of pump failure by type of drug was not assessed. Many Off-Label pumps were exposed to multiplemedications over the life span of the pump. This limits the ability to associate a specific drug, compoundeddrug, drug concentration, or drug combination with increased pump failure risk.

Spasticity Study Population: A total of 1,544 SynchroMed II pumps were classified as On-Label for spasticitytherapy, where there was no evidence of Off-Label drug/admixture exposure. A total of 187 pumps were classifiedas Off-Label where there was evidence of pump exposure to an Off-Label spasticity drug/admixture.

The table below presents SynchroMed II pump survival for the Spasticity indication and is stratified by the On-Labelor Off-Label pump group.

Spasticity study population: Survival from product performance-related pump events for Spasticityindication, by On/Off-Label drug exposure for SynchroMed II pumps

Categorya Time Interval 1 yr 2 yrs 3 yrs 4 yrs 5 yrs 6 yrs 75 mo 78 mo 81 mo

Spasticity Overall

Survival 99.7% 99.7% 99.2% 98.5% 96.6% 94.8% 94.3% 94.3% 94.3%

Numberofpumps

1,176 960 720 537 386 226 141 59 21

Spasticity On-Label

Survival 99.7% 99.7% 99.3% 98.5% 96.6% 94.6% 94.0% 94.0% -

Numberofpumps

1,037 846 633 466 337 196 118 46 -b

Spasticity Off-Label

Survival 100.0% 99.2% 98.1% 98.1% 96.4% 96.4% 96.4% - -

Numberofpumps

139 114 87 71 49 30 23 -b -b


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a Refer to product labeling for approved Spasticity indication.b Sample size is less than 20 active devices at 78 months for Spasticity Off-Label pump group, and at 81 months forboth on-label and off-label pump groups.

The cumulative survival curve of the SynchroMed II pump for the Spasticity indication, and stratified by theOn-Label or Off-Label pump group, is shown below.

SynchroMed II cumulative survival (Spasticity)


View Larger Image

The table and figure below present the complementary cumulative failure rate estimates (Failure=100%-Survival),with the scale of the figure expanded to more clearly show the differences between the groups. Overall the survivalfor the On-Label pumps was similar to the entire pump population (all therapies). There was no statisticallysignificant difference in the risk of failure between the On-Label and Off-Label pumps implanted for the treatment ofSpasticity (p=0.75); however, the limited number of Off-Label pumps may be insufficient to detect a difference.

Spasticity study population: Cumulative failure of SynchroMed II pumps due to product performance-related pump events for Spasticity indication, by On/Off-Label drug exposure

Categorya TimeInterval 1 yr 2 yrs 3 yrs 4 yrs 5 yrs 6 yrs 75 mo 78 mo 81 mo

SpasticityOverall

Failure 0.3% 0.3% 0.8% 1.5% 3.4% 5.2% 5.7% 5.7% 5.7%

Numberofpumps

1,176 960 720 537 386 226 141 59 21

SpasticityOn-Label

Failure 0.3% 0.3% 0.7% 1.5% 3.4% 5.4% 6.0% 6.0% -

Numberofpumps

1,037 846 633 466 337 196 118 46 -b


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SpasticityOff-Label

Failure 0.0% 0.8% 1.9% 1.9% 3.6% 3.6% 3.6% - -

Numberofpumps

139 114 87 71 49 30 23 -b -b

a Refer to product labeling for approved Spasticity indicationb Sample size is less than 20 active devices at 78 months for Spasticity Off-Label pump group, and at 81 months forSpasticity On-Label and Off-Label groups.

SynchroMed II cumulative failure (Spasticity)


View Larger Image


Pump failures have been observed in pumps with both On-Label and Off-Label medications used for allindications over the follow-up period.Off-Label medication exposure is associated with an overall 1.9 times greater risk of pump failure comparedto On-Label medication exposure for the entire pump population. The rate of pump failure accelerates in theOff-Label group after 36 months of follow-up. At 81 months of follow-up, the survival from pump failure forOn-Label pumps was 92.6%, compared to a survival of 84.0% for Off-Label pumps.The data represent the reported registry experience with a median follow-up time of 19.8 months. The longerterm data are based on a lower number of pumps and are subject to change as more follow-up data areobtained via the registry. Survival curve truncation or plateaus do not imply that the implanted devices will notbe adversely impacted beyond the time points of the current data.The On-Label pump group was comprised of 66% spasticity as the indication (1,544 vs. 786: Spasticityversus Pain pumps respectively). On the other hand, the Off-Label group consisted of 95% pain indications(4,910 vs. 187: Pain versus Spasticity pumps respectively).Medication use was recorded as a snapshot at the time of follow-up. It is possible that some On-Label pumpsreceived Off-Label medications in between 6-month follow-up periods. In addition, it is possible that somepumps designated as On-Label received compounded formulation of an On-Label equivalent (i.e. Lioresal)but was not designated as such in the registry database.The time a pump was exposed to an Off-Label medication was not assessed. It is possible that some


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Off-Label pumps were exposed only for a brief time period (e.g. < 6 months).The risk of pump failure by type of drug was not assessed. Many Off-Label pumps were exposed to multiplemedications over the life span of the pump. This limits the ability to associate a specific drug, compoundeddrug, drug concentration, or drug combination with increased pump failure risk.

Catheters

From August 2003 to the report cut-off date of July 31, 2016, there were 8,463 catheters followed in the registry. Thetotal number of catheters was not equal to the total number of pumps (n=9,014) because patients may haveundergone pump replacements but used the same catheters, or patients may have been implanted with Medtronicpumps and non-Medtronic catheters which were not registered with Medtronic Device and Registrant Trackingsystem (DART). The aggregate prospective follow-up time for all catheters was 236,702 months (19,725 years). Thetable below provides the number and percentage of catheters by model.

Catheters by Model

Model Number of Catheters (%)

8709 (InDura) 2,833 (33.5%)

8709SC (InDura 1P) 1,036 (12.2%)

8780 (Ascenda) 701 (8.3%)

8711 (InDura) 652 (7.7%)

8781 (Ascenda) 607 (7.2%)

8731SC (w/ sutureless connector) 222 (2.6%)

Revised Not As Designeda 645 (7.6%)

Grafted Not As Designedb 445 (5.3%)

Other 252 (3.0%)

Revised As Designedc 217 (2.6%)

Ascenda RADd 166 (2.0%)

Catheters No Longer Manufactured

8731 503 (5.9%)

8703W 184 (2.2%)

Total 8,463 (100%)

a Medtronic non-8731 catheters that had been repaired with an 8596 proximal or 8598 distal revision kit.b Catheters that involve the ad-hoc assembly of components other than a Medtronic repair kit or brand new catheter.c 8731 catheters that had been repaired with an 8596 proximal or 8598 distal revision kit.d 8780 or 8781 catheters repaired with the 8782 or 8784 revision kit.


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Catheter Events

Catheter Survival

The figures and tables below represent catheter survival and 95% confidence intervals where at least 20 catheterscontributed to each 3-month interval. Survival curves are only shown if more than 20 devices had at least 12 monthsof follow-up at the time of the report cut-off for each model.

Medtronic catheter repair kits and 2-piece catheters include specially designed connector pins and strain reliefsleeves to splice the catheter segments together. Catheters grafted not as designed, by definition, involve thead-hoc assembly of components other than those from a Medtronic repair kit or brand new catheter. Medtronicrecommends that clinicians follow the labeling for the catheter revision kits.

Model 8709: Survival from Catheter Events


There were 1,064 product performance events reported to the registrythat were related to the catheter. This includes 1,054 events with acatheter etiology, and 10 events with both a catheter and other etiology(including device and non-device etiologies). The majority of the eventswere catheter occlusion (n=276), catheter dislodgement (n=241), breakor cut in the catheter (n=186), or catheter kink (124). Of the 1,064events, 925 were the initial product performance event that affectedcatheter survival estimates.

For the purposes of survival analysis, a device’s follow-up time is cut-offfor one of three reasons: 1) the occurrence of a product performance-related event; 2) the occurrence of a non-product performance-relatedor censoring event; or 3) the device is event-free and censored at thepatient’s last follow-up prior to the data cut-off. For catheters:

925 had follow-up time cut-off due to product performance-relatedevents.5,142 were censored in the survival analysis for the followingreasons: patient expired, catheter explanted/capped, sitetermination, patient discontinued, patient lost to follow-up, othercatheter modification, therapy suspended, or non-productperformance catheter-related event without an associatedintervention.2,396 were free from product performance-related events andcensoring events, were censored at the last follow-up visit prior tothe report cut-off.


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View Larger Image

Catheter Characteristics

Model Number 8709

FDA Approval Date May 1998

Catheters Enrolled 2,833

Catheters Currently Active in Study 288

Device Events 309


Model 8709: Event Summary TableCatheter Event Total

Catheter dislodgement 85



Catheter kink 22

Catheter disconnection at pump 18

Catheter leakage 10

Catheter related complicationa 10



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Medical device complicationb 2



Catheter disconnection between catheter segments 1


Device infusion issuec 1

Motor stall 1


Total Catheter Events 309

a Includes 3 events reported as unable to aspirate catheter, 2 catheter malfunctions, 1 coiled catheter, 1 aneurysmin catheter,1 possible catheter malfunction, 1 unable to aspirate CSF, and 1 difficulty aspirating catheter.b Includes 1 event for pump connector appeared somewhat worn, and 1 for possible catheter corrosion due toconcentration of drug.c Reported as slow dosing at refills.

Time IntervalSurvival(95% Confidence Interval)

Sample Size

1 yr92.1%(90.4%, 93.5%)

963

2 yrs89.4%(87.4%, 91.1%)

908

3 yrs86.1%(83.9%, 88.0%)

847

4 yrs83.2%(80.8%, 85.3%)

752

5 yrs80.6%(78.0%, 82.9%)

626

6 yrs76.0%(73.1%, 78.6%)

533

7 yrs71.3%(68.2%, 74.2%)

440


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8 yrs68.9%(65.6%, 72.0%)

350

9 yrs67.4%(63.9%, 70.6%)

259

10 yrs65.2%(61.5%, 68.7%)

192

11 yrs62.7%(58.6%, 66.5%)

135

12 yrs60.1%(55.5%, 64.3%)

95

13 yrs57.7%(52.5%, 62.5%)

64

14 yrs57.7%(52.5%, 62.5%)

40

15 yrs55.7%(49.4%, 61.6%)

26

Model 8709: Specifications

Total Length 89 cm

Outer diameter (spinal segment) 1.4 mm (4.2 French)

Inner Diameter (spinal segment) 0.53 mm

Catheter Tip Description Closed with 6 side holes

Catheter Volume 0.0022 mL/cm

Trimmable Segments Pump end

Model 8709SC: Survival from Catheter Events



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View Larger Image


Model Number 8709SC


Catheters Enrolled 1,036


Device Events 115


Model 8709SC: Event Summary TableCatheter Event Total





Catheter kink 6

Catheter leakage 6




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Catheter damage 1

Catheter disconnection between catheter segments 1

Device connection issue 1



Product sedimentation present 1

Pump inversion 1


a Includes 3 events reported as catheter malfunction, 1 coiled catheter, 1 catheter occlusion, 1 catheter unable toaspirate, 1 catheter wrapped around pump, and 1 slight loop in catheter.b Reported as sutureless connector failure.


Sample Size

1 yr93.9%(92.0%, 95.4%)

659

2 yrs89.4%(86.9%, 91.5%)

511

3 yrs87.1%(84.3%, 89.4%)

419

4 yrs83.9%(80.7%, 86.7%)

299

5 yrs82.2%(78.6%, 85.2%)

186

6 yrs81.1%(77.2%, 84.4%)

112

7 yrs76.4%(71.0%, 81.0%)

67

8 yrs76.4%(71.0%, 81.0%)

23

at 99 mo76.4%(71.0%, 81.0%)

20


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Model 8709SC: Specifications

Total Length 89 cm

Outer diameter (spinalsegment)

1.4 mm (4.2 French)

Inner Diameter (spinalsegment)

0.53 mm

Catheter Tip DescriptionClosed tip, radiopaque, titanium with 6 sideholes


Trimmable Segments Pump end



View Larger Image


Model Number 8711

FDA Approval Date Oct 1999

Catheters Enrolled 652



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Device Events 86







Catheter kink 5



Catheter access port issue 1

Catheter leakage 1




a Includes 6 events reported as catheter malfunction, 3 unable to aspirate catheter, 2 non-functioning spinalcatheters, 1 no free flow of CSF from spinal segment of catheter, and 1 difficulty aspirating catheter.


Sample Size

1 yr92.5%(88.9%, 94.9%)

309

2 yrs90.0%(86.1%, 92.9%)

286

3 yrs84.9%(80.4%, 88.4%)

252

4 yrs82.7%(78.0%, 86.5%)

219


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5 yrs81.6%(76.7%, 85.5%)

195

6 yrs77.7%(72.3%, 82.2%)

154

7 yrs74.1%(68.3%, 79.1%)

135

8 yrs71.7%(65.5%, 76.9%)

89

9 yrs69.8%(63.2%, 75.5%)

57

10 yrs65.9%(58.1%, 72.5%)

45

11 yrs62.6%(53.9%, 70.2%)

31

12 yrs60.6%(51.1%, 68.7%)

29

13 yrs57.9%(47.3%, 67.0%)

21


Total Length 104.1 cm





Trimmable Segments Spinal and pump ends




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View Larger Image


Model Number 8731




Device Events 50





Catheter kink 3







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a Includes 1 event reported as patency issue with catheter, 1 coiled catheter, and 1 catheter malfunction.


Sample Size

1 yr93.6%(88.8%, 96.3%)

260

2 yrs92.3%(87.5%, 95.3%)

302

3 yrs91.3%(86.5%, 94.4%)

251

4 yrs89.3%(84.3%, 92.8%)

193

5 yrs87.7%(82.4%, 91.5%)

145

6 yrs82.3%(76.1%, 87.0%)

129

7 yrs78.7%(71.9%, 84.0%)

93

8 yrs76.0%(68.6%, 81.8%)

71

9 yrs74.8%(67.2%, 80.9%)

61

10 yrs74.8%(67.2%, 80.9%)

48

11 yrs72.8%(64.2%, 79.7%)

35

at 138 mo72.8%(64.2%, 79.7%)

22



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Catheter Tip Description Closed tip, radiopaque, with 6 side holes

Catheter Volume 2.22mL/cm

Trimmable Segments Spinal end

Model 8731SC: Survival from Catheter Events


View Larger Image


Model Number 8731SC




Device Events 16


Model 8731SC: Event Summary TableCatheter Event Total


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Catheter dislodgment 5


Catheter leakage 1




Sample Size

1 yr94.8%(89.9%, 97.4%)

122

2 yrs91.3%(85.0%, 95.0%)

87

3 yrs90.0%(83.0%, 94.2%)

64

4 yrs88.3%(80.4%, 93.2%)

42

5 yrs86.2%(76.9%, 91.9%)

32

6 yrs86.2%(76.9%, 91.9%)

21

at 81 mo82.2%(68.9%, 90.2%)

23

Model 8731SC: Specifications


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Trimmable Segments Spinal and pump end



View Larger Image


Model Number 8780

FDA Approval Date Sept 2012



Device Events 44




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Catheter kink 8



Catheter leakage 2



a Reported as unable to aspirate catheter.


Sample Size

1 yr93.4%(90.8%, 95.3%)

348

2 yrs90.5%(87.1%, 93.0%)

172

3 yrs89.6%(85.7%, 92.5%)

34

at 39 mo89.6%(85.7%, 92.5%)

22


Total Length 114 cm





Trimmable Segments Connector end of the spinal segment


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View Larger Image


Model Number 8781




Device Events 50



Catheter kink 21





Catheter leakage 1



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Device issue 1




a Reported as possible catheter malfunction.


Sample Size

1 yr87.6%(83.4%, 90.8%)

169

2 yrs85.5%(80.5%, 89.3%)

60

at 33 mo82.5%(75.8%, 87.5%)

28


Total Length 140 cm

Outer diameter (spinalsegment)

1.2 mm (4.0 French)




Trimmable SegmentsCatheter connector ends of the spinal and pumpsegments

Revised As Designed Catheters: Survival from Catheter Events



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View Larger Image


Model Name Revised As Designed




Device Events 33


Revised As Designed Catheters: Event Summary TableCatheter Event Total



Catheter kink 4






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a Includes 1 event reported as catheter malfunction, 1 possible catheter malfunction, and 1 inability to aspiratecatheter.


Sample Size

1 yr92.3%(86.8%, 95.5%)

144

2 yrs89.0%(82.9%, 93.0%)

123

3 yrs86.5%(79.8%, 91.1%)

78

4 yrs82.2%(73.7%, 88.1%)

48

5 yrs80.4%(71.2%, 86.9%)

37

6 yrs75.3%(63.7%, 83.7%)

27

7 yrs67.0%(52.8%, 77.8%)

22

8 yrs67.0%(52.8%, 77.8%)

20

Ascenda Revised As Designed Catheters: Survival from Catheter Events



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View Larger Image


Model Name Ascenda Revised As Designed




Device Events 11


Ascenda Revised As Designed Catheters: Event Summary TableCatheter Event Total





Catheter kink 1

Catheter leakage 1





Sample Size

1 yr92.6%(86.2%, 96.1%)

90

2 yrs91.1%(83.7%, 95.2%)

41

at 30 mo88.1%(77.5%, 93.9%)

23

Revised Not As Designed Catheters: Survival from Catheter Events


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View Larger Image


Model Name Revised Not As Designed

FDA Approval Date NA



Device Events 95


Revised Not As Designed Catheters: Event Summary TableCatheter Event Total




Catheter kink 12



Catheter leakage 3


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Connector block problem 1



a Includes 2 events reported as catheter malfunction, 1 inability to aspirate catheter, 1 poor CSF flow, and 1 catheterwrapped in coils and knots.


Sample Size

1 yr91.0%(88.1%, 93.2%)

441

2 yrs87.6%(84.4%, 90.3% )

356

3 yrs84.2%(80.4%, 87.3%)

263

4 yrs82.4%(78.3%, 85.7%)

186

5 yrs80.7%(76.2%, 84.4%)

115

6 yrs71.8%(64.6%, 77.8%)

63

7 yrs65.2%(56.4%, 72.7%)

37

8 yrs62.5%(52.4%, 71.1%)

21

Grafted Not As Designed Catheters: Survival from Catheter Events



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View Larger Image


Model Name Grafted Not As Designed

FDA Approval Date NA



Device Events 72


Grafted Not As Designed Catheters: Event Summary TableCatheter Event Total




Catheter leakage 4


Catheter kink 3



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Device component issueb 1




a Includes 3 events reported as inability to aspirate catheter, and 1 catheter malfunction.b Reported as broken anchor attributed to the catheter.


Sample Size

1 yr90.3%(86.6%, 93.0%)

267

2 yrs84.5%(79.9%, 88.1%)

207

3 yrs81.4%(76.3%, 85.4%)

158

4 yrs78.2%(72.5%, 82.9%)

97

5 yrs75.5%(69.2%, 80.8%)

64

6 yrs71.9%(64.5%, 78.1%)

47

7 yrs68.8%(60.2%, 75.8%)

43

8 yrs68.8%(60.2%, 75.8%)

37

9 yrs65.0%(55.3%, 73.1%)

28

at 117 mo65.0%(55.3%, 73.1%)

21

Catheter Survival Summary Table


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Model Number FamilyFDAApprovalDate

CathetersEnrolled

CathetersCurrentlyActive inStudy

DeviceEventsa

CumulativeMonthsof Follow-up

8709b 8709May1998

2,833 288 309 81,797

8709SC 8709Mar2006

1,036 291 115 32,258

8711 8711Oct1999

652 156 86 23,973

8731 8731Oct2002

503 71 50 20,109

8731SC 8731Mar2006

222 110 16 5,786

8780 AscendaSept2012

701 500 44 9,810

8781 AscendaSept2012

607 346 50 5,749

Revised As Designed NAOct2002

217 75 33 7,323

Ascenda Revised AsDesigned

NASept2012

166 118 11 2,410

Revised Not AsDesigned

NA NA 645 286 95 20,944

Grafted Not As Designed NA NA 445 180 72 14,426

a There were a total of 1,064 catheter-related events reported to the registry, but only 881 events included in thissummary table. The remaining catheter-related events either occurred in catheter models for which no devicesurvival curves are presented due to an insufficient number of enrolled devices (n=22), or in catheters for which nomodel information was provided (n=22), or were subsequent events (i.e. additional events that occurred after thesurvival censoring event) that did not affect the device survival estimates.b Includes 8709 and 8709AA Models.

Device Survival Probability (95% Confidence Intervals) – Table 1 of 3

Model Number 1 yr 2 yrs 3 yrs 4 yrs 5 yrs

870992.1%(90.4%,

89.4%(87.4%,

86.1%(83.9%,

83.2%(80.8%,

80.6%(78.0%,


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93.5%) 91.1%) 88.0%) 85.3%) 82.9%)

8709SC93.9%(92.0%,95.4%)

89.4%(86.9%,91.5%)

87.1%(84.3%,89.4%)

83.9%(80.7%,86.7%)

82.2%(78.6%,85.2%)

871192.5%(88.9%,94.9%)

90.0%(86.1%,92.9%)

84.9%(80.4%,88.4%)

82.7%(78.0%,86.5%)

81.6%(76.7%,85.5%)

873193.6%(88.8%,96.3%)

92.3%(87.5%,95.3%)

91.3%(86.5%,94.4%)

89.3%(84.3%,92.8%)

87.7%(82.4%,91.5%)

8731SC94.8%(89.9%,97.4%)

91.3%(85.0%,95.0%)

90.0%(83.0%,94.2%)

88.3%(80.4%,93.2%)

86.2%(76.9%,91.9%)

878093.4%(90.8%,95.3%)

90.5%(87.1%,93.0%)

89.6%(85.7%,92.5%)

- -

878187.6%(83.4%,90.8%)

85.5%(80.5%,89.3%)

- - -

Revised As Designed92.3%(86.8%,95.5%)

89.0%(82.9%,93.0%)

86.5%(79.8%,91.1%)

82.2%(73.7%,88.1%)

80.4%(71.2%,86.9%)

Ascenda Revised As Designed92.6%(86.2%,96.1%)

91.1%(83.7%,95.2%)

- - -

Revised Not As Designed91.0%(88.1%,93.2%)

87.6%(84.4%,90.3%)

84.2%(80.4%,87.3%)

82.4%(78.3%,85.7%)

80.7%(76.2%,84.4%)

Grafted Not As Designed90.3%(86.6%,93.0%)

84.5%(79.9%,88.1%)

81.4%(76.3%,85.4%)

78.2%(72.5%,82.9%)

75.5%(69.2%,80.8%)


Model Number 6 yrs 7 yrs 8 yrs 9 yrs 10 yrs

870976.0%(73.1%,78.6%)

71.3%(68.2%,74.2%)

68.9%(65.6%,72.0%)

67.4%(63.9%,70.6%)

65.2%(61.5%,68.7%)


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8709SC81.1%(77.2%,82.2%)

76.4%(71.0%,81.0%)

76.4%(71.0%,81.0%)

- -

871177.7%(72.3%,82.2%)

74.1%(68.3%,79.1%)

71.7%(65.5%,76.9%)

69.8%(63.2%,75.5%)

65.9%(58.1%,72.5%)

873182.3%(76.1%,87.0%)

78.7%(71.9%,84.0%)

76.0%(68.6%,81.8%)

74.8%(67.2%,80.9%)

74.8%(67.2%,80.9%)

8731SC86.2%(76.9%,91.9%)

- - - -

8780 - - - - -

8781 - - - - -

Revised As Designed75.3%(63.7%,83.7%)

67.0%(52.8%,77.8%)

67.0%(52.8%,77.8%)

- -

Ascenda Revised As Designed - - - - -

Revised Not As Designed71.8%(64.6%,77.8%)

65.2%(56.4%,72.7%)

62.5%(52.4%,71.1%)

- -

Grafted Not As Designed71.9%(64.5%,78.1%)

68.8%(60.2%,75.8%)

68.8%(60.2%,75.8%)

65.0%(55.3%,73.1%)

-


Model Number 11 yrs 12 yrs 13 yrs 14 yrs 15 yrs

870962.7%(58.6%,66.5%)

60.1%(55.5%,64.3%)

57.7%(52.5%,62.5%)

57.7%(52.5%,62.5%)

55.7%(49.4%,61.6%)

8709SC - - - - -

871162.6%(53.9%,70.2%)

60.6%(51.1%,68.7%)

57.9%(47.3%,67.0%)

- -

873172.8%(64.2%, - - - -


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79.7%)

8731SC - - - - -

8780 - - - - -

8781 - - - - -

Revised As Designed - - - - -

Ascenda Revised As Designed - - - - -

Revised Not As Designed - - - - -

Grafted Not As Designed - - - - -


Therapies


Resources


Customer Support



© 2017 Medtronic


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© 2017 Medtronic


Study ParticipantsEvent SummarySpinal Cord NeurostimulatorsLeadsExtensions

Study Participants

Centers

The following spinal cord stimulation tables and graphs were generated based on data collected between June 2004and the report cut-off date of July 31, 2016. Seventy-five centers enrolled and contributed patients.

Patients

Of the 4,286 total spinal cord stimulation patients enrolled, 44.6% were implanted for the treatment of “other” painindications, 43.5% were implanted for the treatment of failed back pain, 11.0% were implanted for the treatment ofcomplex regional pain syndrome (CRPS), and 0.9% were implanted for indications that were not specified in thedatabase.

Primary SCS Treatment Indications


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Primary Treatment Indicationa Total Enrolled Patients (Percent)

Other 1,912 (44.6%)

Other chronic pain 765 (17.8%)

Radicular pain syndrome 597 (13.9%)

Other 261 (6.1%)

Degenerative disc disease 168 (3.9%)

Cervical pain 35 (0.8%)

Traumatic nerve injury 31 (0.7%)

Diabetic neuropathy 25 (0.6%)

Post herpetic neuralgia 11 (0.3%)

Facial pain 6 (0.1%)

Angina 4 (0.1%)

Epidural fibrosis 4 (0.1%)

Post herniorrhaphy pain 3 (0.1%)


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Event Summary

There were 2,755 events reported between June 2004 and July 31, 2016 in patients with spinal cord stimulationsystems. Over thirty-seven percent of these events (1,034/2,755) were categorized as product performance-relatedand are presented within this report. The 1,034 product performance events occurred in 490 of the 4,286 totalpatients (11.4%) enrolled. In addition, there were 1,721 non-product performance events. There were also 123deaths reported for patients with spinal cord stimulation systems, none of which were reported as a direct result of aproduct performance event. Early versions of the protocol required events to be reported only when the eventrequired a surgical intervention, resulted in therapy abandonment, or resulted in death. The required event reportingdefinition was expanded in April 2010 to include all adverse events related to the device, implant procedure, and/ortherapy. The event tables provided below include combined data from these versions of the protocol.

Spinal Cord Stimulation System Product Performance Events

Eventa



Percent ofPatients withEvent(n=4,286)

Leadmigration/dislodgement

505 264 6.2%

Chronic cluster headache 2 (<0.1%)

Failed Back Pain 1,863 (43.5%)

Postlaminectomy pain 750 (17.5%)

Failed Back Syndrome (FBS) 625 (14.6%)

Combination back and leg pain 376 (8.8%)

Multiple back operations 83 (1.9%)

Arachnoiditis 21 (0.5%)

Unsuccessful disc surgery 8 (0.2%)

CRPS 472 (11.0%)

CRPS I 361 (8.4%)

CRPS II 111 (2.6%)





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High impedance 226 107 2.5%

Lead fracture 64 41 1.0%

Device stimulationissuec 47 26 0.6%

Low impedance 37 13 0.3%

Neurostimulator unableto recharged 34 32 0.8%

Device malfunctione 24 22 0.5%

Medical devicecomplicationf 17 12 0.3%

Extension fracture 15 10 0.2%

Device breakageg 13 13 0.3%

Device lead damage 7 5 0.1%


5 3 0.1%

Extension migration 5 3 0.1%

Device failureh 4 3 0.1%

Device telemetry issue 4 4 0.1%

Impedance increased 4 3 0.1%

Battery rechargeissued 3 3 0.1%

Device battery issue 3 3 0.1%

Device issue 3 3 0.1%

Device componentissuei 2 2 0.1%

Inadequate leadconnection

2 1 <0.1%


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Paraesthesiaj 2 2 0.1%

Therapeutic productineffective

2 1 <0.1%

Antenna cablebreakage

1 1 <0.1%

Broken bond wire 1 1 <0.1%

Device electricalimpedance issue

1 1 <0.1%

Device kink 1 1 <0.1%

Device lead issue 1 1 <0.1%

Not Codedk 1 1 <0.1%

Totals 1,034 490 11.4%

a Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term or Medtronic’s coding system term forevents that do not exist in the MedDRA dictionary.b The total number of patients may not represent the sum of all rows, as a patient may have experienced more thanone type of event.c Device stimulation issue reported by physician as being caused by neurostimulator (n=2) or lead (n=45).d There were a total of 2,671 patients that used rechargeable SCS neurostimulators in the registry. A total of 1.3%(35/2,671) of patients with a rechargeable SCS neurostimulator experienced a neurostimulator unable to rechargeor battery recharge issue product performance event.e Includes 5 charger malfunctions, 4 patient programmer malfunctions, 3 antenna malfunctions, 2 neurostimulatormalfunctions, 2 events for impedance not measurable, 2 events for non-functional lead electrodes, 1 event for leadimpedance changes, 1 event for error message on programmer, 1 inability to turn neurostimulator on, 1 suspecteddevice malfunction, 1 recharging cable malfunction, and 1 event for neurostimulator stopped working abruptly.f Includes 4 leads no longer providing stimulation, 4 error messages on patient programmer, 2 events reported asunable to pass stylet into lead, 2 leads with open circuits, 1 loose anchor, 1 hybrid anomaly, 1 unknown problem withextension, 1 defective patient programmer, 1 excessive heating of charging unit.g Includes 6 broken charger belts, 1 broken antenna, 1 broken antenna and jack, 1 broken charger, 1 broken patientprogrammer, 1 frayed cord to charger antenna, 1 broken charger cord, and 1 frayed wire to charger.h Includes 2 events for lead failure, 1 event for failure of lead electrodes, and 1 extension failure.i Includes 1 event for damaged antenna cord, and 1 faulty antenna.j Includes 1 event for shocking sensation at battery site and 1 shocking sensation at battery/extension connection.k Event that had not been MedDRA-coded at the time of the report cut-off.

A total of 862 (83.4%) of the 1,034 product performance events were related to the lead, 46 (4.4%) were related to“other device”, 38 (3.7%) were related to “multiple etiologies”, which includes events where at least one device andone non-device etiology was indicated, 29 (2.8%) were related to the neurostimulator, 27 (2.6%) were related to theextension, 19 (1.8%) were related to the recharging process, 6 (0.6%) were related to programming/stimulation, 3(0.3%) were related to “other” etiology, 2 (0.2%) were related to the incisional site/device tract, and 2 (0.2%) wererelated to surgery/anesthesia. Relatedness is determined by the physician.


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aEach event could have more than one etiology.

Spinal Cord Stimulation System Non-Product Performance Events(including adverse eventsa and device events, excluding deaths andnormal battery depletions)

Eventsb Number of Non-ProductPerformance Events

Device issues 550

Device stimulation issuec 295

Battery recharge issued 64

Neurostimulator unable to rechargee 64

Device battery issuef 27

Neurostimulator migration 27

Neurostimulator inversion 19

Device use error 13

Device difficult to use 8

Device malfunctiong 7

Device extrusion 5


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Otherh 21

Therapeutic and nontherapeutic effects(excluding toxicity)

394



No therapeutic response 58

Otherh 5




Implant site extravasation 17


Otherh 29


Implant site infection 74

Device related infection 22

Infection 18

Wound infection 11


Otherh 5

General system disorders Not ElsewhereClassified (NEC)

116

Pain 87

No anomaly found by RPAi 19


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Otherh 10

Procedural related injuries and complicationsNEC

63

Incision site erythema 12

Incision site pain 10

Wound dehiscence 10

Seroma 6

Suture related complication 5

Otherh 20

Neurological disorders NEC 45

Paraesthesia 27

Otherh 18

Musculoskeletal and connective tissuedisorders NEC

44

Pain in extremity 21

Back pain 17

Otherh 6



Otherh 5

Spinal cord and nerve root disorders 15

Radiculopathy 14

Otherh 1

Headaches 10


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Headache 9

Otherh 1

Muscle disorders 9

Muscle spasms 6

Otherh 3

Tissue disorders NEC 8

Impaired healing 8

Otherh 58

Total 1,721

a Adverse events associated with product performance events are not included in this table. Related adverse anddevice events reported on a single event form are represented individually in this table.b Medical Dictionary for Regulatory Activities (MedDRA) High-Level Group Terms and Preferred Terms.c Event reported by the physician with an etiology that was either not device related or had no associated deviceevent.d Events reported as recharge issues not due to a device malfunction.e Patients with these events were unable to recharge due to an issue not related to the device.f Events reported as battery discharge or depletion not due to a device malfunction.g Events were device issues due to patient use or other non-device defect etiology.h Composed of event codes with fewer than 5 events each.i For products that are returned with a suspected device issue, and RPA establishes a root cause or finds noanomaly, results reported herein reflect the finding from Returned Product Analysis (RPA).

There were 123 deaths reported for patients with spinal cord stimulation systems. None of these deaths werereported as a direct result of a product performance event. As indicated, 62 (50.4%) of the deaths occurred inpatients receiving therapy for pain indications in the "other" category, 51 (41.5%) for failed back, and 10 (8.1%) forCRPS.

Death by Primary Indication


Other 62 (50.4%)

Failed Back 51 (41.5%)

CRPS 10 (8.1%)

Total 123 (100%)


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a Refer to product labeling for approved indications

Spinal Cord Neurostimulators

From June 2004 to the report cut-off date of July 31, 2016, 4,731 spinal cord neurostimulators were followed in theregistry. The difference between the total number of patients (N=4,286) versus neurostimulators is due to the factthat some patients had multiple neurostimulators or were subsequently re-implanted. The aggregate prospectivefollow-up time for all spinal cord neurostimulators was 81,755 months (6,813 years). The table below provides thenumber and percentage of spinal cord neurostimulators by model.

Spinal Cord Neurostimulators by Model

Model Number of Neurostimulators (%)

RestoreSensor SureScan MRI (97714) 936 (19.8%)

PrimeAdvanced (37702) 671 (14.2%)

RestoreSensor (37714) 376 (7.9%)

RestoreAdvanced (37713) 357 (7.5%)

PrimeAdvanced SureScan MRI (97702) 421 (8.9%)

RestoreAdvanced SureScan MRI (97713) 99 (2.1%)

Itrel 4 (37703) 74 (1.6%)

RestoreUltra SureScan MRI (97712) 57 (1.2%)

Other/Unspecified 19 (0.4%)

Neurostimulators No Longer Manufactured

RestoreUltra (37712) 581 (12.3%)

Synergy (7427) 461 (9.7%)

Restore (37711) 448 (9.5%)

Itrel 3 (7425) 97 (2.1%)

RestorePrime (37701) 57 (1.2%)

Synergy Versitrel (7427V) 53 (1.1%)

Synergy Plus (7479) 16 (0.3%)

Synergy Compact (7479B) 8 (0.2%)

Total 4,731 (100%)

Neurostimulator Events


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There were 37 product performance-related events with an underlying reported etiology related to spinal cordneurostimulator function. This includes 29 events with a neurostimulator etiology and 8 events with both aneurostimulator and other etiology (including device and non-device etiologies). Of these, 31 were the initial productperformance event that affected neurostimulator survival estimates. For spinal cord neurostimulators in the registry,the current return rate to Medtronic Returned Product Analysis (RPA) was 274/1,118 (25%). The proportion wasbased upon the number of registry spinal cord neurostimulators received by RPA, divided by the total number ofexplanted devices plus the total number of neurostimulators in patients who have expired. One of the 37 spinal cordneurostimulator events was confirmed by Medtronic RPA as a broken bond wire. The neurostimulators with theremaining 36 performance-related events were not returned to Medtronic RPA and the events were assigned asdevice related by the physician. These events included: neurostimulator unable to recharge (n=9), high impedance(n=5), device battery issue (n=3), device malfunction (n=3), lead migration/dislodgement (n=3), medical devicecomplication (n=3), battery recharge issue (n=2), device issue (n=2), device stimulation issue (n=2), deviceconnection issue (n=1), device telemetry issue (n=1), extension migration (n=1), and low impedance (n=1).

For the purposes of survival analysis, a device’s follow-up time is cut-off for one of three reasons: 1) the occurrenceof a product performance-related event; 2) the occurrence of a non-product performance-related or censoring event;or 3) the device is event-free and censored at the patient’s last follow-up prior to the data cut-off. For spinal cordneurostimulators:

31 had follow-up time cut-off due to product performance-related events.3,092 were censored in the survival analysis for the following reasons: patient expired, neurostimulatorexplanted, site termination, patient discontinued, other neurostimulator modification, therapy suspended, ornon-product performance neurostimulator-related event without an associated intervention.1,608 were free from product performance-related events and censoring events, were censored at the lastfollow-up visit prior to the report cut-off.

Neurostimulator Survival

The figures and tables below represent spinal cord neurostimulator survival and 95% confidence intervals where atleast 20 spinal cord neurostimulators contributed to each 3-month interval.

Model 7425 Itrel 3: Survival from Spinal Cord Neurostimulator Events



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View Larger Image

Spinal Cord Neurostimulator Characteristics

Model Name Itrel 3

FDA Approval Date Aug 1995

Neurostimulators Enrolled 97

Neurostimulators Currently Active in Study 1

Device Events 0



Sample Size

1 yr100.0%(NA)

35

2 yrs100.0%(NA)

26

at 30 mo100.0%(NA)

22

Model 7425 Itrel 3: Specifications


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Height 2.2 in (55 mm)

Width 2.4 in (60 mm)


Volume 22 cc

Battery type Non-Rechargeable

Expected Battery life Depends on settings and use (additional Information)

Maximum Electrodes 4

Amplitude 0 - 10.5 V

Rate 2.1 - 130 Hz

Pulse Width 60 - 450 μsec

Groups 1

Programs 1

Implant Depth ≤ 4 cm

Model 37703 Itrel 4: Survival from Spinal Cord Neurostimulator Events


View Larger Image



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Model Name Itrel 4




Device Events 0

Cumulative Months of Follow-up 795


Sample Size

1 yr 100.0% (NA) 37

at 18 mo 100.0% (NA) 21

Model 37703 Itrel 4: Specifications




Volume 28 cc





Rate 2 - 130 Hz


Groups 1

Programs 1


Model 7427 Synergy: Survival from Spinal Cord Neurostimulator Events


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View Larger Image


Model Name Synergy

FDA Approval Date Nov 1999



Device Events 3


Model 7427 Synergy: Event Summary TableNeurostimulator Event Total

Broken bond wire 1

Device stimulation issue 1


Total Neurostimulator Events 3


Sample Size

1 yr100.0%(NA)

208


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2 yrs99.5%(96.6%, 99.9%)

176

3 yrs99.5%(96.6%, 99.9%)

119

4 yrs98.6%(94.4%, 99.7%)

79

5 yrs97.3%(91.4%, 99.2%)

44

6 yrs97.3%(91.4%, 99.2%)

32

7 yrs97.3%(91.4%, 99.2%)

21

at 87 mo97.3%(91.4%, 99.2%)

20

Model 7427 Synergy: Specifications




Volume 51 cc





Rate 3 - 130 Hz


Groups 1

Programs 2


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Model 37701 RestorePrime: Survival from Spinal Cord Neurostimulator Events


View Larger Image


Model Name RestorePrime




Device Events 0



Sample Size

1 yr100.0%(NA)

38

2 yrs100.0%(NA)

23

at 27 mo100.0%(NA)

21


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Model 37701 RestorePrime: Specifications




Volume 39 cc





Rate 2 - 130 Hz


Groups 26

Programs 4


Model 37702 PrimeAdvanced: Survival from Spinal Cord Neurostimulator Events


View Larger Image


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Model Name PrimeAdvanced

FDA Approval Date Jul 2006



Device Events 4


Model 37702 PrimeAdvanced: Event Summary TableNeurostimulator Event Total

Device battery issue 1


High impedance 1

Low impedance 1



Sample Size

1 yr99.8%(98.5%,100.0%)

366

2 yrs99.5%(97.9%,99.9%)

201

3 yrs98.9%(96.1%,99.7%)

95

4 yrs98.9%(96.1%,99.7%)

47

5 yrs98.9%(96.1%,99.7%)

22

Model 37702 PrimeAdvanced: Specifications


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Volume 39 cc


Expected Battery lifeDepends on settings and use(additional Information)



Rate 2 - 130 Hz


Groups 26

Programs 32


Model 37711 Restore: Survival from Spinal Cord Neurostimulator Events


View Larger Image



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Model Name Restore

FDA Approval Date Apr 2005



Device Events 4


Model 37711 Restore: Event Summary TableNeurostimulator Event Total

Neurostimulator unable to recharge 2

Battery recharge issue 1



aReported as suspected device malfunction.


Sample Size

1 yr100.0%(NA)

278

2 yrs100.0%(NA)

221

3 yrs100.0%(NA)

144

4 yrs100.0%(NA)

91

5 yrs100.0%(NA)

71

6 yrs98.3%(88.5%, 99.8%)

53

7 yrs98.3%(88.5%, 99.8%)

41

8 yrs 98.3% 29


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(88.5%, 99.8%)

at 102 mo91.6%(75.3%, 97.3%)

24

Model 37711 Restore: Specifications




Volume 39 cc

Battery type Rechargeable

Expected Battery life 9 years



Rate 2 - 130 Hz


Groups 26

Programs 32


Model 37712 RestoreUltra: Survival from Spinal Cord Neurostimulator Events



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View Larger Image


Model Name RestoreUltra

FDA Approval Date Jan 2008



Device Events 7


Model 37712 RestoreUltra: Event Summary TableNeurostimulator Event Total



Device issue 1




a Reported as malfunction of the spinal cord stimulation system.bReported as error message on patient programmer.

Time Interval Survival Sample Size


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(95% Confidence Interval)

1 yr100%(NA)

334

2 yrs99.6%(97.2%, 99.9%)

195

3 yrs99.1%(96.3%, 99.8%)

130

4 yrs98.1%(93.6%, 99.4%)

88

5 yrs96.4%(89.4%, 98.8%)

58

6 yrs94.4%(85.3%, 97.9%)

31

at 81 mo91.0%(77.6%, 96.5%)

21

Model 37712 RestoreUltra: Specifications




Volume 22 cc





Rate 2 - 1200 Hz


Groups 8

Programs 16


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Model 37713 RestoreAdvanced: Survival from Spinal Cord Neurostimulator Events


View Larger Image


Model Name RestoreAdvanced




Device Events 1


Model 37713 RestoreAdvanced: Event Summary TableNeurostimulator Event Total



a Reported as simulation therapy did not meet patient's expectations.


Sample Size


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1 yr99.6%(97.5%, 99.9%)

224

2 yrs99.6%(97.5%, 99.9%)

155

3 yrs99.6%(97.5%, 99.9%)

95

4 yrs99.6%(97.5%, 99.9%)

60

5 yrs99.6%(97.5%, 99.9%)

44

6 yrs99.6%(97.5%, 99.9%)

32

7 yrs99.6%(97.5%, 99.9%)

21

Model 37713 RestoreAdvanced: Specifications




Volume 39 cc





Rate 2 - 130 Hz


Groups 26

Programs 32


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Model 37714 RestoreSensor: Survival from Spinal Cord Neurostimulator Events


View Larger Image


Model Name RestoreSensor




Device Events 2


Model 37714 RestoreSensor: Event Summary TableNeurostimulator Event Total





Sample Size


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1 yr99.6%(97.4%, 99.9%)

216

2 yrs99.1%(96.1%, 99.8%)

119

3 yrs99.1%(96.1%, 99.8%)

40

at 39 mo99.1%(96.1%, 99.8%)

23

Model 37714 RestoreSensor: Specifications




Volume 22 cc





Rate 2 - 1200 Hz


Groups 8

Programs 16


Model 97702 PrimeAdvanced SureScan MRI: Survival from Spinal Cord Neurostimulator Events



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View Larger Image


Model Name PrimeAdvanced SureScan MRI




Device Events 1


Model 97702 PrimeAdvanced SureScan MRI: Event Summary TableNeurostimulator Event Total




Sample Size

1 yr99.6%(97.0%, 99.9%)

132

2 yrs99.6%(97.0%, 99.9%)

29

Model 97702 PrimeAdvanced SureScan MRI: Specifications


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Volume 39 cc


Expected Battery lifeDepends on settings and use(additional Information)



Rate 3 - 130 Hz


Groups 26

Programs 32


Model 97712 RestoreUltra SureScan MRI: Survival from Spinal Cord Neurostimulator Events


Model Name RestoreUltra SureScan MRI




Device Events 0



Sample Size

at 6 mo100%(NA)

26


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Model 97712 RESTOREULTRA SURESCAN MRI: Specifications




Volume 22 cc





Rate 2 - 1200 Hz


Groups 8

Programs 16


Model 97713 RestoreAdvanced SureScan MRI: Survival from Spinal Cord Neurostimulator Events



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View Larger Image


Model Name RestoreAdvanced SureScan MRI




Device Events 1


Model 97713 RestoreAdvanced SureScan MRI: Event Summary TableNeurostimulator Event Total



aReported as malfunction of spinal cord neurostimulator.


Sample Size

1 yr98.2%(88.1%, 99.7%)

33

at 18 mo98.2%(88.1%, 99.7%)

20

Model 97713 RestoreAdvanced Surescan MRI: Specifications




Volume 39 cc





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Rate 2 - 130 Hz


Groups 26

Programs 32


Model 97714 RestoreSensor SureScan MRI: Survival from Spinal Cord Neurostimulator Events


View Larger Image


Model Name RestoreSensor SureScan MRI




Device Events 6


Model 97714 RestoreSensor SureScan MRI: Event Summary Table


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Neurostimulator Event Total

Lead migration/dislodgement 3

Device telemetry issue 1

High impedance 1




Sample Size

1 yr99.2%(98.0%, 99.7%)

297

2 yrs99.2%(98.0%, 99.7%)

54

at 27 mo99.2%(98.0%, 99.7%)

26

Model 97714 RestoreSensor SureScan MRI: Specifications

Height 54 mm (2.1 in)

Width 54 mm (2.1 in)

Thickness 9 mm (0.4 in)

Volume 22 cc





Rate 2 - 1200 Hz

Pulse Width 60 - 1000 msec

Groups 8


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Programs 16


Spinal Cord Stimulator Survival Summary

Spinal Cord Neurostimulator Survival Summary Table


Neuro-stimulatorsEnrolled

Neuro-stimulatorsCurrentlyActive inStudy

DeviceEventsa


Primary Cell Neurostimulators

Itrel 3 Itrel 3Aug1995

97 1 0 1,425

Itrel 4 Itrel 4May2012

74 64 0 795

Synergy SynergyNov1999

461 9 3 9,396

RestorePrime

RestoreMar2006

57 1 0 1,249

PrimeAdvanced

PrimeAdvanced

Jul2006

671 103 4 12,149

PrimeAdvancedSureScanMRI

PrimeAdvanced

Mar2013

421 326 1 3,625

Rechargeable Neurostimulators

Restore RestoreApr2005

448 13 4 12,959

RestoreUltra

RestoreJan2008

581 65 7 13,240

RestoreAdvanced

RestoreJul2006

357 53 1 9,479

RestoreSensor

RestoreNov2011

376 197 2 6,437

RestoreUltra

RestoreMar2013

57 43 0 405


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SureScanMRI

RestoreAdvancedSureScanMRI

RestoreMar2013

99 76 1 869

RestoreSensorSureScanMRI

RestoreMar2013

936 720 6 8,127

a There were 37 neurostimulator-related events reported to the registry, but only 29 events included in this summarytable. The remaining neurostimulator related events occurred in a model for which no device survival data arepresented due to an insufficient number of enrolled devices (n=2), or were subsequent events (i.e. additional eventsthat occurred after the survival censoring event) that did not affect the device survival estimates.bRestoreUltra SureScan MRI had a device survival probability of 100% at 6 months of follow-up.

Device Survival Probability (95% Confidence Interval)– Table 1 of 2

Model Name 1 yr 2 yrs 3 yrs 4 yrs


Itrel 3100.0%(NA)

100.0%(NA)

- -

Itrel 4100.0%(NA)

- - -

Synergy100.0%(NA)

99.5%(96.6%, 99.9%)

99.5%(96.6%, 99.9%)

98.6%(94.4%, 99.7%)

RestorePrime100.0%(NA)

100.0%(NA)

- -

PrimeAdvanced99.8%(98.5%, 100.0%)

99.5%(97.9%, 99.9%)

98.9%(96.1%, 99.7%)

98.9%(96.1%, 99.7%)

PrimeAdvancedSureScanMRI

99.6%(97.0%, 99.9%)

99.6%(97.0%, 99.9%)

- -


Restore100.0%NA

100.0%NA

100.0%NA

100.0%NA

RestoreUltra100.0%(NA)

99.6%(97.2%, 99.9%)

99.1%(96.3%, 99.8%)

98.1%(93.6%, 99.4%)


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RestoreAdvanced99.6%(97.5%, 99.9%)

99.6%(97.5%, 99.9%)

99.6%(97.5%, 99.9%)

99.6%(97.5%, 99.9%)

RestoreSensor99.6%(97.4%, 99.9%)

99.1%(96.1%, 99.8%)

99.1%(96.1%, 99.8%)

-

RestoreUltraSureScan MRI

-b - - -

RestoreAdvancedSureScan MRI

98.2%(88.1%, 99.7%)

- - -

Restore SensorSureScan MRI

99.2%(98.0%, 99.7%)

99.2%(98.0%, 99.7%)

- -

Device Survival Probability (95% Confidence Interval)– Table 2 of 2

Model Name 5 yrs 6 yrs 7 yrs 8 yrs


Itrel 3 - - - -

Itrel 4 - - - -

Synergy97.3%(91.4%, 99.2%)

97.3%(91.4%, 99.2%)

97.3%(91.4%, 99.2%)

-

RestorePrime - - - -

PrimeAdvanced98.9%(96.1%, 99.7%)

- - -

PrimeAdvancedSureScan MRI

- - - -


Restore100.0%NA

98.3%(88.5%, 99.8%)

98.3%(88.5%, 99.8%)

98.3%(88.5%,99.8%)

RestoreUltra96.4%(89.4%, 98.8%)

94.4%(85.3%, 97.9%)

- -

RestoreAdvanced99.6%(97.5%, 99.9%)

99.6%(97.5%, 99.9%)

99.6%(97.5%, 99.9%)

-

RestoreSensor - - - -

RestoreAdvancedSureScan MRI

- - - -


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Restore SensorSureScan MRI

- - - -

RestoreUltraSureScan MRI

- - - -

Leads

From June 2004 to the report cut-off date of July 31, 2016, there were 7,909 leads followed in the registry.Differences between the total number of leads versus spinal cord neurostimulators (N=4,731) were due to the factthat some patients were subsequently re-implanted with a new lead or were implanted with more than 1 lead. Theaggregate prospective follow-up time for all leads was 150,646 months (12,554 years).

A lead is a set of thin wires with a protective coating and electrodes near the tip (percutaneous lead) or on a paddle(surgical lead). The table below provides the number and percentage of leads by model.

Leads by ModelModel Number of Leads (%)

Pisces Octad Compact (3778)a 2,147 (27.1%)

Vectris SureScan MRI Compact (977A2)a 1,917 (24.2%)

Pisces Standard (3487A)a 963 (12.2%)

Pisces Octad Standard (3777)a 821 (10.4%)

Pisces Plus (3888)a 424 (5.4%)

Specify 5-6-5 (39565)b 271 (3.4%)

Pisces Compact (3887)a 192 (2.4%)

Pisces Octad Subcompact (3776)a 184 (2.3%)

Vectris SureScan MRI Subcompact (977A1)a 105 (1.3%)

Specify 2x8 (39286)b 30 (0.4%)

Specify SureScan MRI 5-6-5 (977C1)b 10 (0.1%)

Specify SureScan MRI 2x8 (977C2)b 2 (<0.1%)


Leads No Longer Manufactured


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Specify (3998)b 149 (1.9%)

Pisces Z Standard (3890)a 140 (1.8%)

Pisces Z Compact (3891)a 123 (1.6%)

Resume TL (3986A)b 104 (1.3%)

Hinged Specify (3999)b 54 (0.7%)

Resume II (3587A)b 52 (0.7%)

Pisces Z Plus (3892)a 24 (0.3%)

On-Point (3987A)b 9 (0.1%)

SymMix (3982A)b 2 (<0.1%)

Total 7,909 (100%)

a Percutaneous leadbSurgical lead

Percutaneous leads composed eighty-nine percent (89.0%) of leads in the registry (7,040/7,909), including 39.9%(3,152/7,909) in the Pisces-Octad lead family, 25.6% (2,022/7,909) in the Vectris SureScan MRI lead family, 20.0%(1,579/7,909) in the Pisces-Quad lead family, and 3.6% (287/7,909) in the Pisces-Quad LZ lead family. Over eightpercent (8.6%) of leads (683/7,909) were surgical leads. A small percent (2.4%) of leads (186/7,909) weredesignated as “Other” or were unspecified in the database.

Lead Events

There were 885 product performance-related events with an underlying reported etiology related to the lead. Thisincludes 862 events with a lead etiology and 23 events with both a lead and other etiology (including device andnon-device etiologies). Of these events, the majority were lead migration/dislodgements (n=500), high impedance(n=207), and lead fracture (n=64). Of the 885 lead events, 757 were the initial product performance event thataffected lead survival estimates. There were 702 events in the 7,040 (10.0%) percutaneous leads, 44 events in the683 (6.4%) surgical leads, and 11 events occurred in a lead with an unknown/other model number.

For the purposes of survival analysis, a device's follow-up time is cut-off for one of three reasons: 1) the occurrenceof a product performance-related event; 2) the occurrence of a non-product performance-related or censoring event;or 3) the device is event-free and censored at the patient's last follow-up prior to the data cut-off. For leads:

757 had follow-up time cut-off due to product performance-related events.4,404 were censored in the survival analysis for the following reasons: patient expired, lead explanted, sitetermination, patient discontinued, other lead modification, therapy suspended, or non-product performancelead-related event without an associated intervention.2,748 were free from product performance-related events and censoring events, were censored at the lastfollow-up prior to the report cut-off.

Lead Survival

The tables below represent annual lead survival and 95% confidence intervals where at least 20 leads contributed to


111 of 202 6/12/17, 9:03 AM

each 3-month interval.

Model 3487A Pisces-Quad: Survival from Lead Events


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Lead Characteristics

Model Number 3487A


Leads Enrolled 963

Leads Currently Active in Study 328

Device Events 182


Model 3487A Pisces-Quad: Event Summary TableLead Event Total

High impedance 74


Low impedance 25



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Lead fracture 13

Inadequate lead connection 2

Total Lead Events 182


Sample Size

1 yr89.8%(86.9%, 92.0%)

464

2 yrs86.8%(83.6%, 89.4%)

380

3 yrs80.0%(76.1%, 83.3%)

311

4 yrs73.6%(69.2%, 77.6%)

224

5 yrs70.4%(65.7%, 74.7%)

184

6 yrs65.3%(60.1%, 70.1%)

145

7 yrs62.3%(56.7%, 67.4%)

107

8 yrs62.3%(56.7%, 67.4%)

93

9 yrs56.1%(49.5%, 62.1%)

70

10 yrs52.6%(45.6%, 59.1%)

59

11 yrs51.5%(44.3%, 58.2%)

40

at 141 mo51.5%(44.3%, 58.2%)

22

Model 3487A Pisces-Quad: Specifications


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Device Name Pisces Standard

Lead Type Percutaneous

Lead

Length (cm) 28, 33, 45, 56

Diameter (mm) 1.3

Electrode

Number 4

Shape Cylindrical

Length (mm) 3.0

Individual Surface Area (mm) 12.0

Inter-Electrode Spacing: Edge to Edge (mm) 6.0

Array Length (mm) 30.0

Model 3887 Pisces-Quad: Survival from Lead Events


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Model Number 3887



114 of 202 6/12/17, 9:03 AM

Leads Enrolled 192


Device Events 22


Model 3887 Pisces-Quad: Event Summary TableLead Event Total


Lead fracture 7

High impedance 3


Device lead damage 1



Sample Size

1 yr91.5%(75.8%, 97.2%)

46

2 yrs81.4%(66.8%, 90.0%)

49

3 yrs76.3%(61.7%, 85.9%)

47

4 yrs74.8%(60.3%, 84.7%)

41

5 yrs72.9%(58.3%, 83.1%)

36

6 yrs70.5%(55.6%, 81.2%)

29

7 yrs68.0%(52.8%, 79.2%)

23

at 90 mo68.0%(52.8%, 79.2%)

21


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Model 3887 Pisces-Quad: Specifications

Device Name Pisces Compact


Lead

Length (cm) 28, 33, 45, 56

Diameter (mm) 1.3

Electrode

Number 4

Shape Cylindrical

Length (mm) 3.0




Model 3888 Pisces-Quad: Survival from Lead Events


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Model Number 3888


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Leads Enrolled 424


Device Events 34


Model 3888 Pisces-Quad: Event Summary TableLead Event Total


High impedance 7


Lead fracture 1



Sample Size

1 yr92.8%(88.2%, 95.6%)

136

2 yrs91.2%(86.1%, 94.5%)

83

3 yrs86.2%(78.6%, 91.2%)

69

4 yrs80.0%(70.9%, 86.5%)

59

5 yrs77.0%(67.1%, 84.2%)

44

6 yrs73.1%(62.1%, 81.4%)

35

7 yrs73.1%(62.1%, 81.4%)

29

8 yrs73.1%(62.1%, 81.4%)

27


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9 yrs73.1%(62.1%, 81.4%)

22

10 yrs73.1%(62.1%, 81.4%)

22

at 123 mo73.1%(62.1%, 81.4%)

22

Model 3888 Pisces-Quad: Specifications

Device Name Pisces Plus


Lead

Length (cm) 28, 33, 45, 56

Diameter (mm) 1.3

Electrode

Number 4

Shape Cylindrical

Length (mm) 6.0




Model 3890 Pisces-Quad LZ: Survival from Lead Events



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Model Number 3890


Leads Enrolled 140


Device Events 10


Model 3890 Pisces-Quad LZ: Event Summary Table

Lead Event Total



Lead fracture 2

High impedance 2


a Includes 2 events reported as impedance not measurable.


Sample Size


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1 yr100.0%(NA)

38

2 yrs97.8%(85.1%, 99.7%)

51

3 yrs89.4%(76.4%, 95.5%)

40

4 yrs89.4%(76.4%, 95.5%)

33

5 yrs83.8%(68.8%, 92.0%)

22

at 66 mo83.8%(68.8%, 92.0%)

20

Model 3890 Pisces-Quad LZ: Specifications

Device name Pisces Z Quad


Lead

Length (cm) 10 - 100

Diameter (mm) 1.3

Electrode

Number 4

Shape Cylindrical

Length (mm) 3.0




Model 3891 Pisces-Quad LZ: Survival from Lead Events



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Model Number 3891


Leads Enrolled 123


Device Events 32


Model 3891 Pisces-Quad LZ: Event Summary Table

Lead Event Total


Lead fracture 6



High impedance 2



Sample Size

1 yr81.7%(71.4%, 88.5%)

56


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2 yrs78.7%(67.9%, 86.2%)

37

at 30 mo63.9%(49.3%, 75.3%)

21

Model 3891 Pisces-Quad LZ: Specifications

Device NamePisces ZQuad Compact


Lead

Length (cm) 10 - 100

Diameter (mm) 1.3

Electrode

Number 4

Shape Cylindrical

Length (mm) 3.0




Model 3776 Pisces-Octad: Survival from Lead Events



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Model Number 3776


Leads Enrolled 184


Device Events 14


Model 3776 Pisces-Octad: Event Summary Table

Lead Event Total


High impedance 2


Lead fracture 1



Sample Size

1 yr91.6%(85.4%, 95.3%)

83


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2 yrs91.6%(85.4%, 95.3%)

61

3 yrs91.6%(85.4%, 95.3%)

38

4 yrs89.0%(79.9%, 94.2%)

23

5 yrs89.0%(79.9%, 94.2%)

20

at 63 mo89.0%(79.9%, 94.2%)

20

Model 3776 Pisces-Octad: Specifications

Device Name1x8Sub-compact


Lead

Length (cm) 45, 60, 75

Diameter (mm) 1.3

Electrode

Number 8

Shape Cylindrical

Length (mm) 3.0







124 of 202 6/12/17, 9:03 AM

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Model Number 3777


Leads Enrolled 821


Device Events 60



Lead Event Total



High impedance 7


Lead fracture 2

Low impedance 2



Sample Size


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1 yr93.0%(90.5%, 94.9%)

423

2 yrs89.7%(86.6%, 92.2%)

265

3 yrs89.7%(86.6%, 92.2%)

157

4 yrs89.1%(85.5%, 91.8%)

100

5 yrs88.1%(83.9%, 91.2%)

72

6 yrs85.2%(79.1%, 89.7%)

55

7 yrs85.2%(79.1%, 89.7%)

36

8 yrs79.4%(68.2%, 87.0%)

25

9 yrs73.0%(58.9%, 83.0%)

32

at 117 mo73.0%(58.9%, 83.0%)

23


Device Name1x8Standard


Lead

Length (cm) 45, 60, 75

Diameter (mm) 1.3

Electrode

Number 8

Shape Cylindrical


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Length (mm) 3.0






View Larger Image


Model Number 3778


Leads Enrolled 2,147


Device Events 257



Lead Event Total


High impedance 34


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Lead fracture 15



Device malfunctionb 2

Impedance increased 1

Low impedance 1


a Includes 2 events reported as lead lost capability of stimulation and 2 events of open circuit on lead.b Includes 2 events reported as lead electrodes not functional.


Sample Size

1 yr89.9%(88.3%, 91.3%)

1,198

2 yrs86.4%(84.5%, 88.1%)

762

3 yrs84.3%(82.1%, 86.2%)

498

4 yrs83.8%(81.5%, 85.8%)

318

5 yrs80.4%(77.3%, 83.0%)

212

6 yrs77.7%(73.9%, 81.1%)

126

7 yrs75.5%(70.9%, 79.5%)

68

8 yrs71.4%(64.6%, 77.1%)

32

at 102 mo71.4%(64.6%, 77.1%)

24



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Device Name1x8Compact


Lead

Length (cm) 45, 60, 75

Diameter (mm) 1.3

Electrode

Number 8

Shape Cylindrical

Length (mm) 3.0




Model 977A1 Vectris SureScan MRI 1x8 Subcompact: Survival from Lead Events


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Model Number 977A1



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Leads Enrolled 105


Device Events 4


Model 977A1 Vectris SureScan MRI 1x8 Subcompact: Event Summary Table

Lead Event Total

Device lead fracture 2


Total Lead Events 4


Sample Size

1 yr97.1%(89.1%, 99.3%)

43

at 18 mo91.1%(76.6%, 96.8%)

22

Model 977A1 Vectris SureScan MRI 1x8 Subcompact: Specifications


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Device NameVectris SureScan MRI1x8 Subcompact


Lead

Length (cm) 60, 75, 90

Diameter (mm) 1.3

Electrode

Number 8

Shape Cylindrical

Length (mm) 3.0




Model 977A2 Vectris SureScan MRI 1x8 Compact: Survival from Lead Events


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Model Number 977A2



Leads Currently Active in Study 1,449

Device Events 86


Model 977A2 Vectris SureScan MRI 1x8 Compact: Event Summary Table

Lead Event Total


High impedance 12

Lead fracture 4

Impedance increased 1

Low impedance 1



Sample Size

1 yr94.2%(92.6%, 95.4%)

595

2 yrs89.9%(86.8%, 92.4%)

138

at 30 mo89.9%(86.8%, 92.4%)

37

Model 977A2 Vectris SureScan MRI 1x8 Compact: Specifications


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Device NameVectris SureScan MRI1x8 Compact


Lead

Length (cm) 60, 75, 90

Diameter (mm) 1.3

Electrode

Number 8

Shape Cylindrical

Length (mm) 3.0




Model 3986A Resume TL: Survival from Lead Events


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Model Number 3986A


133 of 202 6/12/17, 9:03 AM

FDA Clearance DateApr1995

Leads Enrolled 104


Device Events 19


Model 3986A Resume TL: Event Summary Table

Lead Event Total

High impedance 10



Low impedance 2


Lead fracture 1



Sample Size

1 yr84.0%(72.9%, 90.8%)

47

2 yrs84.0%(72.9%, 90.8%)

36

3 yrs81.7%(69.7%, 89.3%)

29

4 yrs81.7%(69.7%, 89.3%)

26

5 yrs81.7%(69.7%, 89.3%)

20

at 63 mo81.7%(69.7%, 89.3%)

20


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Model 3986A Resume TL: Specifications

Device Name Resume TL

Lead Type Surgical

Lead

Length (cm) 25

Diameter (mm) 1.3

Electrode

Number 4

Shape Circle

Length (mm) 4.0

Width (mm) 4.0


Longitudinal Spacing: Edge to Edge (mm) 6.2

Lateral Spacing: Edge to Edge (mm) NA


Array Width (mm) 4.0

Paddle

Length (mm) 44.0

Width (mm) 6.6

Thickness (mm) 1.4

Model 3998 Specify: Survival from Lead Events



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Model Number 3998

FDA Approval Date Feb 1998

Leads Enrolled 149


Device Events 10


Model 3998 Specify: Event Summary Table

Lead Event Total

High impedance 4

Lead fracture 3





Sample Size

1 yr97.0%(88.6%, 99.2%)

59


136 of 202 6/12/17, 9:03 AM

2 yrs91.6%(80.8%, 96.4%)

41

at 33 mo88.5%(75.3%, 94.8%)

26

Model 3998 Specify: Specifications

Device Name Specify

Lead Type Surgical

Lead

Length (cm) 20

Diameter (mm) 1.3

Electrode

Number 8

Shape Rectangular

Length (mm) 3.0

Width (mm) 2.0



Lateral Spacing: Edge to Edge (mm) 2.0



Paddle

Length (mm) 45.0

Width (mm) 7.9

Thickness (mm) 1.8

Model 39565 Specify: Survival from Lead Events



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Model Number 39565

FDA Approval Date Jun 2007

Leads Enrolled 271


Device Events 11


Model 39565 Specify: Event Summary Table

Lead Event Total


High impedance 1



Sample Size

1 yr96.6%(93.0%, 98.4%)

136

2 yrs95.7%(91.5%, 97.9%)

74

3 yrs95.7%(91.5%, 97.9%)

29


138 of 202 6/12/17, 9:03 AM

at 39 mo95.7%(91.5%, 97.9%)

24

Model 39565 Specify: Specifications

Device Name Specify 5-6-5

Lead Type Surgical

Lead

Length (cm) 30, 65

Diameter (mm) 1.3

Electrode

Number 16

Shape Rectangular

Length (mm) 4.0

Width (mm) 1.5



Lateral Spacing: Edge to Edge (mm) 1.0



Paddle

Length (mm) 64.2

Width (mm) 10.0

Thickness (mm) 7.5

Lead Survival Summary


ModelNumber Family

FDAApprovalDate

LeadsEnrolled

Leads CurrentlyActive in Study

DeviceEventsa



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Percutaneous Leads

3487A Pisces-Quad May 1988 963 328 182 28,621

3887 Pisces-Quad Jan 1997 192 56 22 4,598

3888 Pisces-Quad Nov 1992 424 74 34 7,935

3890Pisces-QuadLZ

Sep 2002 140 18 10 2,986

3891Pisces-QuadLZ

Sep 2002 123 12 32 2,315

3776 Pisces-Octad Nov 2005 184 37 14 3,816

3777 Pisces-Octad Apr 2005 821 149 60 17,564

3778 Pisces-Octad Apr 2005 2,147 428 257 48,813

977A1VectrisSureScan

Mar 2013 105 75 4 1,023

977A2VectrisSureScan

Mar 2013 1,917 1,449 86 16,566

Surgical Leads

3986A Resume TL Apr 1995b 104 35 19 2,893

3998 Specify Feb 1998 149 20 10 2,992

39565 Specify Jun 2007 271 120 11 4,441

a There were a total of 885 lead-related events reported to the registry, but only 741 events included in this summarytable. The remaining lead-related events occurred in lead models for which no device survival data are presenteddue to an insufficient number of enrolled devices (n=5), leads with an unknown model number (n=11), or weresubsequent device events (i.e. additional events that occurred after the survival censoring event) that did not affectthe survival estimates.b FDA clearance date.

Device Survival Probability (95% Confidence Interval) – Table 1 of 3

ModelNumber

Family 1 yr 2 yrs 3 yrs 4 yrs

Percutaneous Leads

3487A Pisces-Quad89.8%(86.9%, 92.0%)

86.8%(83.6%, 89.4%)

80.0%(76.1%, 83.3%)

73.6%(69.2%, 77.6%)


140 of 202 6/12/17, 9:03 AM

3887 Pisces-Quad91.5%(75.8%, 97.2%)

81.4%(66.8%, 90.0%)

76.3%(61.7%, 85.9%)

74.8%(60.3%, 84.7%)

3888 Pisces-Quad92.8%(88.2%, 95.6%)

91.2%(86.1%, 94.5%)

86.2%(78.6%, 91.2%)

80.0%(70.9%, 86.5%)

3890 Pisces-Quad LZ100.0%(NA)

97.8%(85.1%, 99.7%)

89.4%(76.4%, 95.5%)

89.4%(76.4%, 95.5%)

3891 Pisces-Quad LZ81.7%(71.4%, 88.5%)

78.7%(67.9%, 86.2%)

- -

3776 Pisces-Octad91.6%(85.4%, 95.3%)

91.6%(85.4%, 95.3%)

91.6%(85.4%, 95.3%)

89.0%(79.9%, 94.2%)

3777 Pisces-Octad93.0%(90.5%, 94.9%)

89.7%(86.6%, 92.2%)

89.7%(86.6%, 92.2%)

89.1%(85.5%, 91.8%)

3778 Pisces-Octad89.9%(88.3%, 91.3%)

86.4%(84.5%, 88.1%)

84.3%(82.1%, 86.2%)

83.8%(81.5%, 85.8%)

977A1 Vectris SureScan97.1%(89.1%, 99.3%)

- - -

977A2 Vectris SureScan94.2%(92.6%, 95.4%)

89.9%(86.8%, 92.4%)

- -

Surgical Leads

3986A Resume TL84.0%(72.9%, 90.8%)

84.0%(72.9%, 90.8%)

81.7%(69.7%, 89.3%)

81.7%(69.7%, 89.3%)

3998 Specify97.0%(88.6%, 99.2%)

91.6%(80.8%, 96.4%)

- -

39565 Specify96.6%(93.0%, 98.4%)

95.7%(91.5%, 97.9%)

95.7%(91.5%, 97.9%)

-


ModelNumber

Family 5 yrs 6 yrs 7 yrs 8 yrs

Percutaneous Leads

3487A Pisces-Quad70.4%(65.7%, 74.7%)

65.3%(60.1%, 70.1%)

62.3%(56.7%, 67.4%)

62.3%(56.7%, 67.4%)


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3887 Pisces-Quad72.9%(58.3%, 83.1%)

70.5%(55.6%, 81.2%)

68.0%(52.8%, 79.2%)

-

3888 Pisces-Quad77.0%(67.1%, 84.2%)

73.1%(62.1%, 81.4%)

73.1%(62.1%, 81.4%)

73.1%(62.1%, 81.4%)

3890 Pisces-Quad LZ83.8%(68.8%, 92.0%)

- - -

3891 Pisces-Quad LZ - - - -

3776 Pisces-Octad89.0%(79.9%, 94.2%)

- - -

3777 Pisces-Octad88.1%(83.9%, 91.2%)

85.2%(79.1%, 89.7%)

85.2%(79.1%, 89.7%)

79.4%(68.2%, 87.0%)

3778 Pisces-Octad80.4%(77.3%, 83.0%)

77.7%(73.9%, 81.1%)

75.5%(70.9%, 79.5%)

71.4%(64.6%, 77.1%)

977A1 Vectris SureScan - - - -

977A2 Vectris SureScan - - - -

Surgical Leads

3986A Resume TL81.7%(69.7%, 89.3%)

- - -

3998 Specify - - - -

39565 Specify - - - -


ModelNumber

Family 9 yrs 10 yrs 11 yrs

Percutaneous Leads

3487A Pisces-Quad56.1%(49.5%, 62.1%)

52.6%(45.6%, 59.1%)

51.5%(44.3%, 58.2%)

3887 Pisces-Quad - - -

3888 Pisces-Quad73.1%(62.1%, 81.4%)

73.1%(62.1%, 81.4%)

-

3890 Pisces-Quad LZ - - -


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3891 Pisces-Quad LZ - - -

3776 Pisces-Octad - - -

3777 Pisces-Octad73.0%(58.9%, 83.0%)

- -

3778 Pisces-Octad - - -

977A1 Vectris SureScan - - -

977A2 Vectris SureScan - - -

Surgical Leads

3986A Resume TL - - -

3998 Specify - - -

39565 Specify - - -

Extensions

From June 2004 to the report cut-off date of July 31, 2016, there were 3,275 extensions followed in the registry.Differences between the total number of extensions versus spinal cord neurostimulators (N=4,731) were due to thefact that some systems did not use an extension. The aggregate prospective follow-up time for all extensions was77,026 months (6,419 years).

An extension is a set of thin wires with a protective coating that connects the neurostimulator to the lead. The tablebelow provides the number and percentage of extensions by model.

Extensions by ModelModel Number of Extensions (%)

37081 (1x8) 1,377 (42.0%)

37082 (bifurcated stretch coil) 614 (18.7%)

37083 (single stretch coil) 222 (6.8%)


Extensions No Longer Manufactured

7489 (Low profile quadripolar) 746 (22.8%)

7495 (quadripolar in-line) 264 (8.1%)


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7472 (bifurcated 1x8) 21 (0.6%)

7496 (quadripolar) 9 (0.3%)

7471 (1x8) 8 (0.2%)

Total 3,275 (100%)

Extension Events

There were 31 product performance-related events with an underlying reported etiology related to the extension.This includes 27 events with an extension etiology and 4 events with both an extension and other etiology (includingdevice and non-device etiologies). Of these events, the majority were extension fractures (n=15). Of the 31 events,27 were the initial product performance event that affected extension survival estimates.

For the purposes of survival analysis, a device’s follow-up time is cut-off for one of three reasons: 1) the occurrenceof a product performance-related event; 2) the occurrence of a non-product performance-related or censoring event;or 3) the device is event-free and censored at the patient’s last follow-up prior to the data cut-off. For extensions:

27 had follow-up time cut-off due to product performance-related events.2,433 were censored in the survival analysis for the following reasons: patient expired, extension explanted,site termination, patient discontinued, other extension modification, therapy suspended, or non-productperformance extension-related event without an associated intervention.815 were free from product performance-related events and censoring events, were censored at the lastfollow-up visit prior to the report cut-off.

Extension Survival

The figures and tables below represent extension survival and 95% confidence intervals where at least 20extensions contributed to each 3-month interval.

Model 37081: Survival from Extension Events



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Extension Characteristics

Model Number 37081


Extensions Enrolled 1,377

Extensions Currently Active in Study 423

Device Events 9


Model 37081 Extension: Event Summary Table

Extension Event Total

Extension fracture 6

Extension migration 1

High impedance 1

Low impedance 1

Total Extension Events 9


Sample Size

1 yr99.8%(99.1%, 99.9%)

707


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2 yrs99.1%(97.9%, 99.6%)

424

3 yrs98.5%(97.0%, 99.3%)

246

4 yrs98.5%(97.0%, 99.3%)

160

5 yrs98.5%(97.0%, 99.3%)

113

6 yrs98.5%(97.0%, 99.3%)

74

7 yrs98.5%(97.0%, 99.3%)

49

8 yrs98.5%(97.0%, 99.3%)

29

at 99 mo98.5%(97.0%, 99.3%)

25


Device Name 1x8 Extension

Length (cm) 20, 40, 60

Distal End Compatibility 1 Octad Lead

Distal End Set Screws 1

Proximal End INS Compatibility Restore Family




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Model Number 37082


Extensions Enrolled 614


Device Events 5






Paraesthesiaa 1


a Reported as shocking sensation at battery/extension connection.


Sample Size

1 yr99.6%(98.3%, 99.9%)

403


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2 yrs99.3%(97.9%, 99.8%)

274

3 yrs99.3%(97.9%, 99.8%)

176

4 yrs99.3%(97.9%, 99.8%)

125

5 yrs99.3%(97.9%, 99.8%)

98

6 yrs99.3%(97.9%, 99.8%)

76

7 yrs96.4%(89.1%, 98.8%)

51

8 yrs96.4%(89.1%, 98.8%)

34

at 105 mo96.4%(89.1%, 98.8%)

21


Device Name Bifurcated Stretch-Coil Extension

Length (cm) 20, 40, 60

Distal End Compatibility 2 Quad Leads

Distal End Set Screws 8 (4 per Lead)





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Model Number 37083




Device Events 5





Device failurea 1



a Reported as extension failure


Sample Size

1 yr99.1%(94.1%, 99.9%)

122


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2 yrs97.3%(92.0%, 99.1%)

97

3 yrs96.2%(90.0%, 98.6%)

54

4 yrs96.2%(90.0%, 98.6%)

42

5 yrs96.2%(90.0%, 98.6%)

31

6 yrs96.2%(90.0%, 98.6%)

28

7 yrs96.2%(90.0%, 98.6%)

26

at 87 mo96.2%(90.0%, 98.6%)

21


Device Name Single Stretch-Coil Extension

Length (cm) 20, 40, 60

Distal End Compatibility 1 Quad Lead






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View Larger Image


Model Number 7489




Device Events 4








a Reported as unknown problem with extension


Sample Size

1 yr99.1% (96.5%, 99.8%)

294


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2 yrs99.1%(96.5%, 99.8%)

290

3 yrs98.3% (95.6%, 99.4%)

205

4 yrs98.3% (95.6%, 99.4%)

138

5 yrs98.3% (95.6%, 99.4%)

103

6 yrs98.3% (95.6%, 99.4%)

80

7 yrs98.3% (95.6%, 99.4%)

63

8 yrs98.3% (95.6%, 99.4%)

61

9 yrs98.3% (95.6%, 99.4%)

60

10 yrs98.3% (95.6%, 99.4%)

53

11 yrs98.3% (95.6%, 99.4%)

42

at 138 mo98.3% (95.6%, 99.4%)

30


Device Name Low Profile Quad Extension

Length (cm) 10, 25, 40, 51, 66

Distal End Compatibility 1 Quad Lead


Proximal End INS Compatibility Itrel 3, Synergy, Versitrel

Extension Survival Summary


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ModelNumber

FamilyFDAApprovalDate

ExtensionsEnrolled

Extensions CurrentlyActive in Study

DeviceEventsa

Cumulative Monthsof Follow-up

37081 37081Apr2005

1,377 423 9 27,730

37082 37082Mar2006

614 178 5 18,102

37083 37083Sep2005

222 51 5 5,691

7489 7489Oct2002

746 97 4 17,761

a There were a total of 31 extension-related events reported to the registry, but only 23 events are included in thissummary table. The remaining extension-related events occurred in an extension model for which no device survivaldata is presented due to an insufficient number of enrolled devices (n=4), or were subsequent device events (i.e.additional events that occurred after the survival censoring event) that did not affect the survival estimates.



3708199.8%(99.1%, 99.9%)

99.1%(97.9%, 99.6%)

98.5%(97.0%, 99.3%)

98.5%(97.0%, 99.3%)

98.5%(97.0%, 99.3%)

3708299.6%(98.3%, 99.9%)

99.3%(97.9%, 99.8%)

99.3%(97.9%, 99.8%)

99.3%(97.9%, 99.8%)

99.3%(97.9%, 99.8%)

3708399.1%(94.1%, 99.9%)

97.3%(92.0%, 99.1%)

96.2%(90.0%, 98.6%)

96.2%(90.0%, 98.6%)

96.2%(90.0%, 98.6%)

748999.1%(96.5%, 99.8%)

99.1%(96.5%, 99.8%)

98.3%(95.6%, 99.4%)

98.3%(95.6%, 99.4%)

98.3%(95.6%, 99.4%)


Model Number 6 yrs 7 yrs 8 yrs 9 yrs 10 yrs 11 yrs

3708198.5%(97.0%, 99.3%)

98.5%(97.0%, 99.3%)

98.5%(97.0%, 99.3%)

- - -

3708299.3%(97.9%, 99.8%)

96.4%(89.1%, 98.8%)

96.4%(89.1%, 98.8%)

- - -

3708396.2%(90.0%, 98.6%)

96.2%(90.0%, 98.6%)

- - - -


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748998.3%(95.6%, 99.4%)

98.3%(95.6%, 99.4%)

98.3%(95.6%, 99.4%)

98.3%(95.6%, 99.4%)

98.3%(95.6%, 99.4%)

98.3%(95.6%, 99.4%)


Therapies


Resources


Customer Support



© 2017 Medtronic

© 2017 Medtronic


Study ParticipantsEvent SummaryDeep Brain NeurostimulatorsLeadsExtensions


154 of 202 6/12/17, 9:03 AM

Study Participants

Centers

The following deep brain stimulation tables and graphs were generated based on data collected between July 2009and the report cut-off date of July 31, 2016. Thirty-six centers enrolled and contributed patients to the deep brainstimulation section of the report.

Patients

Of the 2,109 deep brain stimulation patients enrolled, 67.1% were implanted for the treatment of Parkinson’sDisease, 21.3% were implanted for the treatment of Essential Tremor, 7.1% were implanted for the treatment ofDystonia, 2.0% were implanted for the treatment of some other indication, 1.6% were implanted for indications thatwere not specified in the database, 0.7% were implanted for the treatment of Obsessive Compulsive Disorder, and0.2% were implanted for the treatment of Epilepsy.

Primary DBS Treatment Indications


Parkinson's Disease 1,416 (67.1%)

Essential Tremor 449 (21.3%)

Dystonia 150 (7.1%)

OCD 14 (0.7%)


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Epilepsy 5 (0.2%)

Other 42 (2.0%)




Event Summary

There were 715 events reported between July 2009 and July 31, 2016 in patients with deep brain stimulationsystems. Of these events, 17.3% (124/715) were categorized as product performance-related and are presentedgraphically within this report. The 124 product performance events occurred in 74 of the 2,109 total patients (3.5%)enrolled. In addition, there were 591 non-product performance events reported. There were also 78 deaths reportedfor patients with deep brain stimulation systems. None of these deaths were reported as a direct result of a productperformance event.

Deep Brain Stimulation System Product Performance Events

Eventa



Percent ofPatients withEvent(N=2,109)




13 7 0.3%

Medical devicecomplicationc 10 8 0.4%

Device malfunction 6 3 0.1%

Neurostimulator unableto recharged 5 5 0.2%

Extension fracture 3 3 0.1%

Extension migration 3 2 0.1%


Device breakage 2 2 0.1%


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Deep Brain Stimulation System Product Performance Events


2 1 <0.1%

Impedance increased 2 1 <0.1%

Device defective 1 1 <0.1%

Device failure 1 1 <0.1%

Device migration 1 1 <0.1%

Electromagneticinterference

1 1 <0.1%

Lead insulation breach 1 1 <0.1%

Totals 124 74 3.5%

a Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term or Medtronic's coding system term forevents that do not exist in the MedDRA dictionary.b The total number of patients may not represent the sum of all rows, as a patient may have experienced more thanone type of event.c Includes 2 events for extension cable loop, 2 events for extension twisting, 1 event reported as open circuit to lead,1 antenna heating while recharging, 1 suspicion of heating of the antenna while recharging, 1 undesirableinteraction with external electronic device, 1 short circuit, and 1 issue with controller not communicating.d There were 254 patients that used rechargeable neurostimulators for DBS in the registry. A total of 2.0% (5/254) ofpatients with a rechargeable neurostimulator experienced a neurostimulator unable to recharge event.

A total of 50 (40.3%) of the 124 product performance events were related to the lead, 26 (21.0%) were related to"multiple etiologies", which includes events where at least one device and one non-device etiology was indicated, 18(14.5%) were related to the extension, 9 (7.3%) were related to the neurostimulator, 6 (4.8%) were related to therecharging process, 6 (4.8%) were related to surgery/anesthesia, 5 (4.0%) were related to other devices, 3 (2.4%)were related to programming/stimulation, and 1 (0.8%) was related to some "other" etiology. Relatedness isdetermined by the physician.



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a Each event could have more than one etiology.

Deep Brain Stimulation System Non-Product Performance Events(including adverse eventsa and device events, excluding deaths andnormal battery depletions)


Movement disorders (including parkinsonism) 83

Tremor 37

Dyskinesia 21

Dystonia 12

Bradykinesia 3

Parkinson's disease 3

Otherc 7



Postoperative wound infection 6

Wound infection 6


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Device related infection 4

Infection 4

Otherc 8

Device issues 75



Neurostimulator unable to recharged 4


Otherc 13

Neurological disorders Not ElsewhereClassified (NEC)

56

Dysarthria 17

Paraesthesia 12

Balance disorder 9

Speech disorder 9

Otherc 9




Implant site inflammation 6

Implant site haematoma 4

Otherc 13

Depressed mood disorders and disturbances 32


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Depression 30

Otherc 2


25

Wound dehiscence 14

Otherc 11

Injuries NEC 22

Fall 9

Subdural haematoma 6

Otherc 7

General system disorders NEC 17

Gait disturbance 9

Pain 3

Otherc 5

Anxiety disorders and symptoms 11

Anxiety 8

Otherc 3

Deliria (including confusion) 11

Confusional state 8

Delirium 3

Psychiatric and behavioural symptoms NEC 11

Abnormal behaviour 11

Central nervous system vascular disorders 10


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Cerebral haematoma 4

Haemorrhage intracranial 4

Otherc 2

Mental impairment disorders 8

Cognitive disorder 4

Otherc 4

Mood disorders and disturbances NEC 7

Apathy 3

Otherc 4

Physical examination and organ system statustopics

7

Weight increased 7

Seizures (including subtypes) 7

Convulsion 4

Otherc 3

Suicidal and self-injurious behaviours NEC 7

Suicidal ideation 5

Otherc 2


5

Musculoskeletal stiffness 3

Otherc 2

Disturbances in thinking and perception 4

Hallucination 4


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Pulmonary vascular disorders 3

Pulmonary embolism 3

Otherc 69

Total 591

a Adverse events associated with product performance events are not included in this table.b Medical Dictionary for Regulatory Activities (MedDRA) High-Level Group Terms and Preferred Terms orMedtronic's own coding system terms for events that do not exist in the MedDRA dictionary.c Composed of event codes with fewer than 3 events each.d Patients were unable to recharge their neurostimulators due to an issue not related to the device.

There were 78 deaths reported for patients with deep brain stimulation systems. None of these deaths werereported as a direct result of a product performance event. A total of 66 (84.6%) deaths occurred in patientsreceiving therapy for Parkinson’s disease and 12 (15.4%) for Essential Tremor.



Parkinson's Disease 66 (84.6%)

Essential Tremor 12 (15.4%)

Total 78 (100%)

a Refer to product labeling for approved indications

Neurostimulators

From July 2009 to the report cut-off date of July 31, 2016, 2,462 deep brain neurostimulators were followed in theregistry. The difference between the total number of patients (N=2,109) versus neurostimulators is due to the factthat some patients have more than one neurostimulator implanted or were subsequently re-implanted. Theaggregate prospective follow-up time for all neurostimulators was 36,458 months (3,038 years). The table belowprovides the number and percentage of neurostimulators by model.

Neurostimulators by Model

Model Number of Neurostimulators (%)

Activa PC (37601) 1,440 (58.5%)

Activa SC (37602/37603) 663 (26.9%)

Activa RC (37612) 257 (10.4%)



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Neurostimulators No Longer Manufactured

Soletra (7426) 68 (2.8%)

Kinetra (7428) 12 (0.5%)

Total 2,462 (100%)


There were 12 product performance-related events with an underlying reported etiology related to deep brainneurostimulator function. This includes 9 events with a neurostimulator etiology, and 3 with both a neurostimulatorand other etiology (including device and non-device etiologies). All 12 of these events were the initial productperformance event that affected neurostimulator survival estimates. For neurostimulators in the registry, the currentreturn rate to Medtronic Returned Product Analysis (RPA) was 28/409 (6.8%). The proportion was based upon thenumber of registry neurostimulators received by RPA, divided by the total number of explanted devices plus the totalnumber of deep brain stimulation devices in patients who have expired. There were no anomalies found in the 28devices that were returned for analysis. The 12 deep brain neurostimulators with performance-related events werenot returned to Medtronic RPA but were assigned as device-related by the physician as high impedance (n=5),device malfunction (n=2), medical device complication (n=2), device connection issue (n=1), electromagneticinterference (n=1), and impedance increased (n=1).

For the purposes of survival analysis, a device's follow-up time is cut-off for one of three reasons: 1) the occurrenceof a product performance-related event; 2) the occurrence of a non-product performance-related or censoring event;or 3) the device is event-free and censored at the patient’s last follow-up prior to the data cut-off. Forneurostimulators:

12 had follow-up time cut-off due to a product performance-related event.852 were censored in the survival analysis for the following reasons: patient expired, neurostimulatorexplanted, patient discontinued, therapy suspended, other neurostimulator modification, site termination, ornon-product performance neurostimulator-related event without an associated intervention.1,598 were free from product performance-related events and censoring events, were censored at the lastfollow-up visit prior to the report cut-off.


The figures and tables below represent neurostimulator survival and 95% confidence intervals where at least 20neurostimulators contributed to each 3-month interval.

Model 37601 Activa PC: Survival from Neurostimulator Events



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View Larger Image

Deep Brain Neurostimulator Characteristics

Model Name Activa PC


Neurostimulators Enrolled 1,440

Neurostimulators Currently Active in Study 1,031

Device Events 7


Model Activa PC: Event Summary Table



Device connection issuee 1

Electromagnetic interference 1

High impedancea 1

Impedance increasedb 1

Medical device complicationc 1


a Reported as high impedance attributed to leads, neurostimulator and extensions.bReported as increased impedance attributed to the neurostimulator and extension.


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cReported as undesirable interaction with external electronic device.


Sample Size

1 yr99.6%(99.0%, 99.9%)

706

2 yrs99.3%(98.3%, 99.7%)

285

3 yrs99.3%(98.3%, 99.7%)

106

4 yrs99.3%(98.3%, 99.7%)

27

at 51 mo99.3%(98.3%, 99.7%)

23

Model 37601 Activa PC: Specifications




Volume 39 cc




Amplitude0 - 10.5 V (voltage mode)0 - 25.5 mA (current mode)

Rate2 - 250 Hz (voltage mode)30 - 250 Hz (current mode)


Groups 4

Programs 16 (up to 4 per group)


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Models 37602 & 37603 Activa SC: Survival from Neurostimulator Events


View Larger Image


Model Name Activa SC




Device Events 3


Model Activa SC: Event Summary Table


High impedancea 2



a Includes 2 events reported as high impedance attributed to neurostimulator, leads and extensions.b Reported as short circuit.

Time Interval Survival Sample Size


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(95% Confidence Interval)

1 yr99.4%(98.0%, 99.8%)

327

2 yrs99.4%(98.0%, 99.8%)

159

3 yrs99.4%(98.0%, 99.8%)

54

at 45 mo99.4%(98.0%, 99.8%)

27

Models 37602 & 37603 Activa SC: Specifications




Volume28 cc (Model 37602)27 cc (Model 37603)







Groups 4



Model 37612 Activa RC: Survival from Neurostimulator Events



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View Larger Image


Model Name Activa RC




Device Events 2


Model Activa RC: Event Summary Table


High impedancea 2


aIncludes 1 events reported as high impedance attributed to the neurostimulator, extension and lead, and 1 for highimpedance attributed to the neurostimulator.


Sample Size

1 yr99.5%(96.8%, 99.9%)

132

2 yrs98.6%(94.0%, 99.7%)

69


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3 yrs98.6%(94.0%, 99.7%)

38

at 42 mo98.6%(94.0%, 99.7%)

24

Model 37612 Activa RC: Specifications




Volume 22 cc







Groups 4



Model 7426 Soletra: Survival from Neurostimulator Events


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View Larger Image


Model Name Soletra




Device Events 0



Sample Size

1 yr100.0%(NA)

44

2 yrs100.0%(NA)

27

27 mo100.0%(NA)

20

Model 7426 Soletra: Specifications


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Volume 22 cc

Battery type Non-rechargeable




Rate 3 - 185 Hz


Groups 1

Programs 1


Deep Brain Neurostimulator Survival Summary





DeviceEvents


Activa PC ActivaApr2009

1,440 1,031 7 20,638

Activa SC ActivaJan2011

663 387 3 9,725

Activa RC ActivaMar2009

257 175 2 4,268

Soletra SoletraJan2002

68 4 0 1,427

Device Survival Probability (95% Confidence Interval)


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ModelName 1 yr 2 yrs 3 yrs 4 yrs

Activa PC99.6%(99.0%, 99.9%)

99.3%(98.3%, 99.7%)

99.3%(98.3%, 99.7%)

99.3%(98.3%, 99.7%)

Activa SC99.4%(98.0%, 99.8%)

99.4%(98.0%, 99.8%)

99.4%(98.0%, 99.8%)

-

Activa RC99.5%(96.8%, 99.9%)

98.6%(94.0%, 99.7%)

98.6%(94.0%, 99.7%)

-

Soletra100.0%(NA)

100.0%(NA)

- -

Leads

From July 2009 to the report cut-off date of July 31, 2016, there were 3,293 leads followed in the registry.Differences between the total number of leads versus the total number of neurostimulators (N=2,462) were due tothe fact that some patients were implanted with more than 1 lead or were subsequently re-implanted with a newlead. The aggregate prospective follow-up time for all leads was 57,102 months (4,758 years).

A lead is a set of thin wires with a protective coating and electrodes near the tip. The table below provides thenumber and percentage of leads by model.

Leads by Model

Model Number Number of Leads (%)

3389 (compact electrode spacing) 1,852 (56.2%)

3387 (standard electrode spacing) 1,408 (42.8%)

3391 22 (0.7%)


Total 3,293 (100%)

Lead Events

There were 66 product performance-related events with an underlying reported etiology related to the lead. Thisincludes 50 events with a lead etiology and 16 events with both a lead and other etiology (including device andnon-device etiologies). Thirty-seven events were high impedance, 13 were lead fracture, 8 were leadmigration/dislodgement, 3 were low impedance, 2 were device malfunction, 1 was medical device complication, 1was device defective, and 1 was device failure. Of the 66 events, 38 were the initial product performance event thataffected lead survival estimates.

For the purposes of survival analysis, a device’s follow-up time is cut-off for one of three reasons: 1) the occurrenceof a product performance-related event; 2) the occurrence of a non-product performance-related or censoring event;or 3) the device is event-free and censored at the patient's last follow-up prior to the data cut-off. For leads:

38 had follow-up time cut-off due to product performance-related events.828 were censored in the survival analysis for the following reasons: patient expired, lead explanted, patientdiscontinued, site termination, therapy suspended, or other lead modification, or non-product performance


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lead-related event without an associated intervention.2,427 were free from product performance-related events and censoring events, were censored at the lastfollow-up prior to the report cut-off.

Lead Survival

The figure and tables below represent lead survival and 95% confidence intervals where at least 20 leadscontributed to each 3-month interval.

Model 3387: Survival from Lead Events


View Larger Image


Model Number 3387




Device Events 10


Model 3387: Event Summary Table

Lead Event Total


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High impedance 6

Lead fracture 1

Low impedance 1




a Reported as open circuit of lead.


Sample Size

1 yr99.3%(98.5%, 99.7%)

675

2 yrs99.1%(98.0%, 99.6%)

341

3 yrs99.1%(98.0%, 99.6%)

187

4 yrs99.1%(98.0%, 99.6%)

114

5 yrs97.8%(92.9%, 99.3%)

49

6 yrs97.8%(92.9%, 99.3%)

32

7 yrs97.8%(92.9%, 99.3%)

42

8 yrs97.8%(92.9%, 99.3%)

38

9 yrs97.8%(92.9%, 99.3%)

29

at 117 mo94.2%(80.4%, 98.4%)

20



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Model Number 3387

Lead

Length (cm) 40

Diameter (mm) 1.27

Electrode

Number 4

Shape Cylindrical

Length (mm) 1.5

Individual Surface Area (mm2) 6.0

Inter-Electrode Spacing: Edge to Edge(mm)

1.5




View Larger Image


Model Number 3389




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Leads Currently Active in Study 1,440

Device Events 27



Lead Event Total

High impedance 18

Lead fracture 5


Device defective 1

Low impedance 1



Sample Size

1 yr99.0%(98.2%, 99.4%)

779

2 yrs98.1%(96.9%, 98.9%)

398

3 yrs97.5%(95.8%, 98.5%)

234

4 yrs96.3%(93.7%, 97.9%)

148

5 yrs95.6%(92.2%, 97.5%)

118

6 yrs93.0%(88.1%, 95.9%)

95

7 yrs93.0%(88.1%, 95.9%)

85

8 yrs93.0%(88.1%, 95.9%)

59

9 yrs93.0%(88.1%, 95.9%)

28


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at 111 mo93.0%(88.1%, 95.9%)

23


Model Number 3389

Lead

Length (cm) 40

Diameter (mm) 1.27

Electrode

Number 4

Shape Cylindrical

Length (mm) 1.5



0.5




ModelNumber Family

FDAApprovalDate

LeadsEnrolled


DeviceEventsa


3387 3387 Jan 2002 1,408 994 10 25,137

3389 3389 Sep 1999 1,852 1,440 27 31,496

a There were a total of 66 lead-related events reported to the registry, but only 37 events included in this summarytable. The remaining lead-related events occurred in a lead model for which no device survival data are presenteddue to an insufficient number of enrolled devices (n=1) or were subsequent events (i.e. additional events thatoccurred after the survival censoring event) that did not affect the device survival estimates.


ModelNumber

Family 1 yr 2 yrs 3 yrs 4 yrs

3387 338799.3%(98.5%, 99.7%)

99.1%(98.0%, 99.6%)

99.1%(98.0%, 99.6%)

99.1%(98.0%, 99.6%)


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3389 338999.0%(98.2%, 99.4%)

98.1%(96.9%, 98.9%)

97.5%(95.8%, 98.5%)

96.3%(93.7%, 97.9%)


ModelNumber

Family 5 yrs 6 yrs 7 yrs 8 yrs 9 yrs

3387 338797.8%(92.9%, 99.3%)

97.8%(92.9%, 99.3%)

97.8%(92.9%, 99.3%)

97.8%(92.9%, 99.3%)

97.8%(92.9%, 99.3%)

3389 338995.6%(92.2%, 97.5%)

93.0%(88.1%, 95.9%)

93.0%(88.1%, 95.9%)

93.0%(88.1%, 95.9%)

93.0%(88.1%, 95.9%)

Extensions

From July 2009 to the report cut-off date of July 31, 2016, there were 3,307 extensions followed in the registry.Differences between the total number of extensions versus the total number of neurostimulators (N=2,462) were dueto the fact that some patients were implanted with more than 1 extension or subsequently re-implanted with anextension. In addition, the number of extensions does not equal the number of leads (N=3,293) because somepatients were re-implanted with a new lead using existing extensions. The aggregate prospective follow-up time forall extensions was 56,121 months (4,677 years).

An extension is a set of thin wires with a protective coating that connects the neurostimulator to the lead. The tablebelow provides the number and percentage of extensions by model.

Extensions by Model

Model Number of Extensions (%)

37086a (quadripolar stretch) 2,782 (84.1%)


Extensions No Longer Manufactured

7482 (quadripolar) 431 (13.0%)

Total 3,307 (100%)

a Includes Models 37085 and 37086

Extension Events

There were 23 product performance-related events with an underlying reported etiology related to the extension.This includes 18 events with an extension etiology and 5 events with both an extension and other etiology (includingdevice and non-device etiologies). Eleven events were high impedance attributed to the extensions, 4 were medicaldevice complications, 3 were extension fractures, 2 were extension migrations, 1 was device malfunction, 1 wasdevice connection issue, and 1 was impedance increased. Of the 23 events, 15 were the initial product performanceevent that affected extension survival estimates.

For the purposes of survival analysis, a device's follow-up time is cut-off for one of three reasons: 1) the occurrenceof a product performance-related event; 2) the occurrence of a non-product performance-related or censoring event;or 3) the device is event-free and censored at the patient’s last follow-up prior to the data cut-off. For extensions:

15 extensions had follow-up time cut-off due to product performance-related events.


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850 were censored in the survival analysis for the following reasons: patient expired, extension explanted, sitetermination, patient discontinued, therapy suspended, other extension modification, or non-productperformance extension-related event without an associated intervention.2,442 were free from product performance-related events and censoring events, were censored at the lastfollow-up visit prior to the report cut-off.

Extension Survival

The figure and tables below represent extension survival and 95% confidence intervals where at least 20 extensionscontributed to each 3-month interval.



View Larger Image


Model Number 37086


Extensions Enrolled 2,782

Extensions Currently Active in Study 2,063

Device Events 15





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High impedance 7




Impedance increasedb 1


a Includes 2 events for extension cable loop, and 2 events for twisting of extensions.b Reported as increased impedance attributed to the neurostimulator and extension.


Sample Size

1 yr99.5%(99.0%, 99.7%)

1,407

2 yrs99.3%(98.8%, 99.6%)

699

3 yrs99.3%(98.8%, 99.6%)

378

4 yrs99.3%(98.8%, 99.6%)

190

5 yrs98.3%(94.7%, 99.5%)

57

at 69 mo98.3%(94.7%, 99.5%)

29

Model 37086 Extension: Specifications

Device Name Stretch-Coil® DBS Extension

Length (cm) 40, 40, 95

Distal End Compatibility 3387, 3389, or 3391 DBS lead


Proximal End INS CompatibilityActiva® RC, Activa PC, or Activa SC37603


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ModelNumber


ExtensionsEnrolled


DeviceEventsa


37086b 37086 Sep 2009 2,782 2,063 15 46,254



37086b 99.5%(99.0%, 99.7%)

99.3%(98.8%, 99.6%)

99.3%(98.8%, 99.6%)

99.3%(98.8%, 99.6%)

98.3%(94.7%, 99.5%)

a There were a total of 23 extension-related events reported to the registry, but only 15 events included in thissummary table. The remaining events were subsequent events that did not affect the device survival estimates.b Includes Models 37085 and 37086


Therapies


Resources


Customer Support



© 2017 Medtronic

© 2017 Medtronic


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Study ParticipantsEvent SummaryNeurostimulatorsLeadsExtensions

Study Participants

Centers

The following sacral neuromodulation tables and graphs were generated based on data collected between April2010 and the report cut-off date of July 31, 2016. Nineteen centers enrolled and contributed patients to the sacralneuromodulation section of the report.

Patients

Of the 756 sacral neuromodulation patients enrolled, the primary indications for implant were as follows: 39.9% wereimplanted for the treatment of urinary urge incontinence, 33.2% were implanted for the treatment of urgency-frequency, 9.7% were implanted for the treatment of urinary retention, 5.8% were implanted for the treatment ofsome other indication, 5.3% were implanted for the treatment of fecal incontinence, 2.5% were implanted for thetreatment of interstitial cystitis, 1.1% were implanted for the treatment of chronic pelvic pain syndrome, 0.3% wereimplanted for the treatment of bladder pain syndrome, and 2.2% were implanted for indications that were notspecified in the database.

Primary SNM Treatment Indications

Sacral Neuromodulation Primary Treatment Indications


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Urinary Urge Incontinence 302 (39.9%)

Urgency-Frequency 251 (33.2%)

Urinary Retention 73 (9.7%)

Fecal Incontinence 40 (5.3%)

Interstitial Cystitis 19 (2.5%)

Chronic Pelvic Pain Syndrome 8 (1.1%)

Painful Bladder Syndrome 2 (0.3%)

Other 44 (5.8%)


Total Patients 756



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Event Summary

There were 300 events reported between April 2010 and July 31, 2016 in patients with sacral neuromodulationsystems. Of these events, 23.0% (69/300) were categorized as product performance-related and are presentedgraphically within this report. The 69 product performance events occurred in 57 of the 756 total patients (7.5%)enrolled. In addition, there were 231 non-product performance events reported. There were also 16 deaths reportedfor patients with sacral neuromodulation systems, none of which were reported as a direct result of a productperformance event.

Sacral Neuromodulation System Product Performance Events

Eventa


Number ofPatients withEvent

Percent ofPatients withEvent(n=756)



12 11 1.5%



Device battery issue 4 1 0.1%

Device electricalimpedance issue

2 1 0.1%

Device malfunctionb 2 2 0.3%

Device lead damage 1 1 0.1%

Device lead issue 1 1 0.1%

Device telemetry issue 1 1 0.1%

Lead migration 1 1 0.1%

Total 69 57 7.5%

a Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term or Medtronic's coding system term forevents that do not exist in the MedDRA dictionary.b Includes 1 event reported as device function could not be restored after a fall and 1 neurostimulator malfunction.

A total of 55 (79.7%) of the 69 product performance events were related to the lead, 6 (8.7%) were related to theneurostimulator, 3 (4.3%) were related to the extension, 2 (2.9%) were related to "multiple etiologies", whichincludes events where at least one device and one non-device etiology was indicated, 1 (1.4%) was related to some"other device", 1 (1.4%) was related to some "other etiology", and 1 (1.4%) was related to programming/stimulation.Relatedness is determined by the physician.



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aEach event could have more than one etiology.

Sacral Neuromodulation System Non-Product Performance Events(including adverse eventsa and device events, excluding deaths andnormal battery depletions)



Urinary tract infectionc 83


Wound infection 4


Cystitis 1

Infection 1

Postoperative wound infection 1

Therapeutic and nontherapeutic effects(excluding toxicity)

29



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Device issues 20



Neurostimulator inversion 2

Device extrusion 1

Urinary tract signs and symptoms 13

Urinary incontinence 5

Micturition urgency 3

Urge incontinence 2

Bladder pain 1

Incontinence 1

Urinary retention 1

Neurological disorders Not ElsewhereClassified (NEC)

11

Paraesthesia 9

Restless legs syndrome 1

Sensory disturbance 1

General system disorders NEC 9

Pain 5


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No anomaly found by RPAd 1

Oedema 1

Sensation of pressure 1

Swelling 1

Bacterial infectious disorders 4

Staphylococcal infection 2

Cellulitis 1

Implant site cellulitis 1

Therapeutic procedures and supportive careNEC

4

Incisional drainage 3

Wound drainage 1



Epidermal and dermal conditions 2

Rash 1

Skin reaction 1


2

Groin pain 1

Pain in extremity 1

Reproductive tract disorders NEC 2

Pelvic pain 2

Anal and rectal conditions NEC 1


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Proctalgia 1

Bone disorders (excluding congenital andfractures)

1

Bone pain 1

Genitourinary tract disorders NEC 1

Urinary tract disorder 1

Joint disorders 1

Arthralgia 1


1

Procedural complication 1

Vulvovaginal disorders (excluding infectionsand inflammations)

1

Vulvovaginal pain 1

Totals 231

a Adverse events associated with product performance events are not included in this table.b Medical Dictionary for Regulatory Activities (MedDRA) High-Level Group Terms and Preferred Terms orMedtronic's own coding system terms for events that do not exist in the MedDRA dictionary.c Therapy relevant event collected per registry protocol but not device related.d For products that are returned with a suspected device issue, and RPA establishes a root cause or finds noanomaly, results reported herein reflect the finding from Returned Product Analysis (RPA).

There were 16 deaths reported for patients with sacral neuromodulation systems, none of which were reported as adirect result of a product performance event. Eight deaths occurred in patients receiving therapy for urgency-frequency, 4 deaths for other indications, 3 deaths for urinary urge incontinence and 1 for urinary retention.



Urgency-frequency 8 (50.0%)

Otherb 4 (25.0%)

Urinary urge incontinence 3 (18.8%)


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Urinary retention 1 (6.3%)

Total 16 (100%)

a Refer to product labeling for approved indications.b Includes 1 indication of atony of bladder, 1 of neurogenic bladder, 1 of BPH without urinary obstruction, and 1 ofurinary tract infection.

Neurostimulators

From April 2010 to the report cut-off date of July 31, 2016, 705 neurostimulators were followed in the registry. Thedifference between the total number of patients (n=756) versus neurostimulators (n=705) is due to the fact thatpatients could enroll prior to implant but may not have received an implanted device, or patients were enrolled butnot implanted before the data cut-off.

Over eighty-six percent (86.5%) of neurostimulators were InterStim II (n=610), and 13.5% (n=95) were InterStim.The aggregate prospective follow-up time for all neurostimulators was 11,523 months (960 years).


There were 6 product performance-related events with an underlying reported etiology related to neurostimulatorfunction. All 6 of these events were the initial product performance event that affected neurostimulator survivalestimates. For neurostimulators in the registry, the current return rate to Medtronic Returned Product Analysis (RPA)was 14/82 (17%). The proportion was based upon the number of registry neurostimulators received by RPA, dividedby the total number of explanted devices plus the total number of stimulation devices in patients who have expired.There were no anomalies found in the 14 devices that were returned for analysis. The 6 neurostimulators withperformance-related events were not returned to Medtronic RPA but were assigned as device-related by thephysician as high impedance (n=2), device malfunction (n=2), device electrical impedance issue (n=1), and devicebattery issue (n=1).

For the purposes of survival analysis, a device's follow-up time is cut-off for one of three reasons: 1) the occurrenceof a product performance-related event; 2) the occurrence of a non-product performance-related or censoring event;or 3) the device is event-free and censored at the patient's last follow-up prior to the data cut-off. Forneurostimulators:

6 had follow-up cut-off due to product performance-related events.292 were censored in the survival analysis for the following reasons: patient expired, neurostimulatorexplanted, patient discontinued, therapy suspended, other neurostimulator modification, or non-productperformance neurostimulator-related event with no associated intervention.407 were free from product performance-related events and censoring events, were censored at the lastfollow-up visit prior to the report cut-off.


The figure and tables below represent neurostimulator survival and 95% confidence intervals where at least 20neurostimulators contributed to each 3-month interval.

Model 3023 InterStim: Survival from Neurostimulator Events


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Neurostimulator Characteristics

Model Name InterStim




Device Events 1a


aEvent occurred at 37 months of follow-up.

Model 3023 InterStim: Event Summary Table





Sample Size

1 yr 100.0% (NA) 57

2 yrs 100.0% (NA) 44

3 yrs 100.0% (NA)a 24


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aEvent occurred at 37 months of follow-up.

Model 3023 InterStim: Specifications




Volume 25 cc





Rate 2.1 - 130 Hz


Programs 4


Model 3058 InterStim II: Survival from Neurostimulator Events


View Larger Image


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Model Name InterStim II

FDA Approval Date Jun 2006



Device Events 5


Model 3058 InterStim II: Event Summary Table


High impedancea 2

Device malfunctionb 2

Device electrical impedance issue 1


a Includes 2 events reported as high impedance attributed to both lead and neurostimulator.b Includes 1 event reported as device function could not be restored after a fall and 1 neurostimulator malfunction.


Sample Size

1 yr99.7%(98.0%, 100.0%)

323

2 yrs97.9%(94.9%, 99.2%)

145

3 yrs97.9%(94.9%, 99.2%)

54

45 mo97.9%(94.9%, 99.2%)

27

Model 3058 InterStim II: Specifications


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Volume 14 cc




Amplitude 0 - 8.5 V

Rate 2.1 - 130 Hz


Programs 4

Implant Depth ≤ 2.5 cm

Neurostimulator Survival Summary





DeviceEventsa


InterStim InterStimJul1998

95 61 1 2,115

InterStim II InterStimJun2006

610 362 5 9,409

Device Survival Probability (95% Confidence Interval)Model Name 1 yr 2 yrs 3 yrs

InterStim100.0%NA

100.0%NA

100.0%NA

InterStim II99.7%(98.0%, 100.0%)

97.9%(94.9%, 99.2%)

97.9%(94.9%, 99.2%)

a The event for the InterStim device occurred at 37 months of follow-up, a point beyond which the survival estimatesare provided due to a low number of active devices (less than 20).


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Leads

From April 2010 to the report cut-off date of July 31, 2016, there were 695 leads followed in the registry. Differencesbetween the total number of leads versus the total number of neurostimulators (N=705) were due to the fact thatsome patients were subsequently re-implanted with a new neurostimulator. The aggregate prospective follow-uptime for all leads was 11,314 months (943 years).

A lead is a set of thin wires with a protective coating and electrodes near the tip. The table below provides thenumber and percentage of leads by model.

Leads by Model

Model Number of Leads (%)

3889 (tined) 604 (86.9%)

Unspecified 2 (0.3%)

Leads No Longer Manufactured

3093 (tined) 85 (12.2%)

3080 3 (0.4%)

3092 1 (0.1%)

Total 695 (100%)

Lead Events

There were 57 product performance-related events with an underlying reported etiology related to the lead. Thisincludes 55 events with a lead etiology and 2 events with both a lead and other etiology (including device andnon-device etiologies). The majority of the events were high impedance (n=28). Of the 57 product performance-related lead events, 49 were the initial product performance event that affected lead survival estimates.

For the purposes of survival analysis, a device's follow-up time is cut-off for one of three reasons: 1) the occurrenceof a product performance-related event; 2) the occurrence of a non-product performance-related or censoring event;or 3) the device is event-free and censored at the patient's last follow-up prior to the data cut-off. For leads:

49 had follow-up time cut-off due to product performance-related events.249 were censored in the survival analysis for the following reasons: patient expired, lead explanted, patientdiscontinued, other lead modification, therapy suspended, or non-product performance lead-related eventwithout an associated intervention.397 were free from product performance-related events and censoring events, were censored at the lastfollow-up prior to the report cut-off.

Lead Survival

The figures and tables below represent lead survival and 95% confidence intervals where at least 20 leadscontributed to each 3-month interval.



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View Larger Image


Model Number 3889


Leads Enrolled 604


Device Events 44



Lead Event Total

High impedance 22


Lead fracture 7

Low impedance 6

Device electrical impedance issue 1



Sample Size


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1 yr95.2%(92.6%, 96.9%)

293

2 yrs89.8%(85.6%, 92.8%)

139

3 yrs81.0%(73.5%, 86.6%)

56

4 yrs79.4%(71.1%, 85.5%)

29

at 54 mo76.0%(65.0%, 84.0%)

20

Model 3889 Tined Lead: Specifications

Model Number 3889

Lead

Length (cm) 28, 33, 41

Diameter (mm) 1.27

Electrode

Number 4

Shape Cylindrical/coiled

Length (mm) 3.0



3.0





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Model Number 3093


Leads Enrolled 85


Device Events 4



Lead Event Total


High impedance 1

Lead fracture 1


Total Lead Events 4


Sample Size

1 yr98.3%(88.5%, 99.8%)

48


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2 yrs93.6%(81.3%, 97.9%)

29

at 27 mo93.6%(81.3%, 97.9%)

25

Model 3093 Tined Lead: Specifications

Model Number 3093

Lead

Length (cm) 28, 33, 41

Diameter (mm) 1.27

Electrode

Number 4

Shape Cylindrical/coiled

Length (mm) 3.0 (3x) and 10.2 (1x)

Individual Surface Area (mm2) 12.0 and 40.7





ModelNumber Family

FDAApprovalDate

LeadsEnrolled


DeviceEventsa


3889 3889 Sep 2002 604 375 44 9,454

3093 3093 Sep 2002 85 41 4 1,780

a There were 57 lead-related events reported to the registry, but only 48 events included in this summary table. Theremaining events occurred in a lead model for which no device survival curve is presented due to an insufficientnumber of enrolled devices (i.e., Model 3080) (n=1) or were subsequent events (i.e. additional events that occurredafter the survival censoring event) that did not affect the device survival estimates.

Device Survival Probability (95% Confidence Interval)ModelNumber

1 yr 2 yrs 3 yrs 4 yrs


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388995.2%(92.6%, 96.9%)

89.8%(85.6%, 92.8%)

81.0%(73.5%, 86.6%)

79.4%(71.1%, 85.5%)

309398.3%(88.5%, 99.8%)

93.6%(81.3%, 97.9%)

- -

Extensions

From April 2010 to the report cut-off date of July 31, 2016, there were 94 extensions followed in the registry.Differences between the total number of extensions versus the total neurostimulators (N=705) were due to the factthat not all systems require an extension.

An extension is a set of thin wires with a protective coating that connects the neurostimulator to the lead (notrequired for all neurostimulation systems). All the extensions were Model 3095. The aggregate prospective follow-uptime for all extensions was 2,185 months (182 years).

Extension Events

There were 3 product performance-related events with an underlying reported etiology related to the extension. Ofthese 3 events, 1 was the initial product performance event that affected extension survival estimates.

For the purposes of survival analysis, a device’s follow-up time is cut-off for one of three reasons: 1) the occurrenceof a product performance-related event; 2) the occurrence of a non-product performance-related or censoring event;or 3) the device is event-free and censored at the patient’s last follow-up prior to the data cut-off. For extensions:

1 had follow-up time cut-off due to product performance-related events.33 were censored in the survival analysis for the following reasons: patient expired, extension explanted,patient discontinued, or therapy suspended.60 were free from product performance-related events and censoring events and were censored at the lastfollow-up visit prior to the report cut-off.

Extension Survival

The figure and table below represent extension survival and 95% confidence intervals where at least 20 extensionscontributed to each 3-month interval unless otherwise noted.




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Model Number 3095




Device Events 1



Lead fracturea 1


aLead fracture attributed to both the lead and extension.


Sample Size

1 yr 100.0% (NA) 56

2 yrs 98.0% (86.8%, 99.7%) 40

at 33 mo 98.0% (86.8%, 99.7%) 24

Model 3095 Extension: Specifications


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Device Name Quadripolar Extension

Length (cm) 10, 25, 51

Distal End Compatibility Tined lead models 3889 and 3093


Proximal End INS Compatibility InterStim Model 3023



ModelNumber


ExtensionsEnrolled


DeviceEventsa


3095 3095 Jul 1998 94 61 1 2,185


Model Number 1 yr 2 yrs

3095100.0%NA

98.0%(86.8%, 99.7%)

a There were a total of 3 extension-related events reported to the registry, but only 1 event included in this summarytable. The remaining events were subsequent events (i.e. additional events that occurred after the survivalcensoring event) that did not affect the device survival estimates.


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